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Undersøgelse til evaluering af BL-B01D1 hos patienter med metastatisk eller uoperabel ikke-småcellet lungekræft (NSCLC)

15. september 2026 opdateret af: SystImmune Inc.

Et fase 1-studie, der evaluerer sikkerheden, tolerabiliteten og effektiviteten af ​​BL-B01D1 hos personer med metastatisk eller ikke-operabel ikke-småcellet lungekræft

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with metastatic or unresectable NSCLC and Other Solid Tumors.

This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day 1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a continuous 21-day treatment cycle. Each Cohort has different dose groups.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
540

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Rekruttering
        • Beverly Hills Cancer Center
        • Ledende efterforsker:
          • Afshin Gabayan, MD
        • Kontakt:
      • Duarte, California, Forenede Stater, 91010
        • Rekruttering
        • City of Hope Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Adam Rock, MD
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • University of California Irvine Medical Center
        • Ledende efterforsker:
          • Cathleen Park, MD
        • Kontakt:
      • Santa Monica, California, Forenede Stater, 90404
        • Rekruttering
        • UCLA Santa Monica
        • Ledende efterforsker:
          • Jonathan Goldman, MD
        • Kontakt:
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Rekruttering
        • University of Colorado Cancer Center
        • Ledende efterforsker:
          • Tejas Patil, MD
        • Kontakt:
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Rekruttering
        • Yale University, Yale Cancer Center
        • Ledende efterforsker:
          • Scott Gettinger, MD
        • Kontakt:
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20007
    • Florida
      • Miami, Florida, Forenede Stater, 33125
        • Rekruttering
        • Sylvester Comprehensive Cancer Center
        • Ledende efterforsker:
          • Gilberto Lopes, MD
        • Kontakt:
      • Orlando, Florida, Forenede Stater, 32827
        • Rekruttering
        • Sara Cannon Research Institute Lake Nona
        • Ledende efterforsker:
          • Cesar Perez Batista, MD
        • Kontakt:
      • Port Saint Lucie, Florida, Forenede Stater, 34952
        • Rekruttering
        • Hematology - Oncology Associates of the Treasure Coast
        • Ledende efterforsker:
          • Nicholas Iannotti, MD
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Northwestern University Feinberg School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Young Chae, MD
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Rekruttering
        • University of Iowa Hospital and Clinics
        • Ledende efterforsker:
          • Sneha Phadke, MD
        • Kontakt:
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
      • Boston, Massachusetts, Forenede Stater, 02215
        • Rekruttering
        • Dana-Farber Cancer Institute
        • Kontakt:
        • Ledende efterforsker:
          • Janne Pasi, MD, PhD
    • New York
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center Head Neck Services
        • Ledende efterforsker:
          • Helena Yu, MD
        • Kontakt:
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Rekruttering
        • Sarah Cannon - Tennessee Oncology
        • Ledende efterforsker:
          • Melissa Johnson, MD
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77030
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • University of Texas M.D. Anderson Cancer Center
        • Ledende efterforsker:
          • Yasir Elamin, MD
        • Kontakt:
          • Yasir Elamin
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Rekruttering
        • University of Washington Fred Hutchinson
        • Ledende efterforsker:
          • Christina Baik, MD
        • Kontakt:
  • Frankrig
      • Lyon, Frankrig, 69373
      • Paris, Frankrig, 75013
        • Rekruttering
        • Groupe Hospitalier Pitie-Salpetriere
        • Kontakt:
        • Ledende efterforsker:
          • Johanna Wassermann, MD
      • Saint-Herblain, Frankrig, 44805
        • Rekruttering
        • Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
        • Ledende efterforsker:
          • Sandrine Hiret, MD
        • Kontakt:
      • Villejuif, Frankrig, 94800
  • Italien
      • Candiolo, Italien, 10060
        • Rekruttering
        • Fondazione del Piemonte per l'Oncologia IRCC Candiolo
        • Ledende efterforsker:
          • Vanesa Gregorc, MD
        • Kontakt:
      • Rozzano, Italien, 20089
        • Rekruttering
        • IRCCS Istituto Clinico Humanitas, Cancer Center
        • Ledende efterforsker:
          • Matteo Simonelli, MD
        • Kontakt:
  • Japan
      • Chūōku, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Noboru Yamamoto, MD
  • Spanien
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Ledende efterforsker:
          • Enriqueta Felip Font, MD
        • Kontakt:
      • Barcelona, Spanien, 8041
        • Rekruttering
        • Hospital de la Santa Creu I Sant Pau
        • Kontakt:
        • Ledende efterforsker:
          • Margarita Majem Tarruella, MD
      • Madrid, Spanien, 28040
        • Rekruttering
        • START Madrid / Hospital Universitario Fundacion Jimenez Diaz
        • Kontakt:
        • Ledende efterforsker:
          • Ester Garcia Lorenzo, MD
      • Madrid, Spanien, 28050
        • Rekruttering
        • START Madrid / Centro Integral Oncologico Clara Campal
        • Kontakt:
        • Ledende efterforsker:
          • Ramon Yarza Barrio, MD
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 De Octubre
        • Ledende efterforsker:
          • Santiago Ponce Aix, MD
        • Kontakt:
      • Madrid, Spanien, 28007
        • Rekruttering
        • Hospital Beata María Ana
        • Kontakt:
        • Ledende efterforsker:
          • Javier Cortes, MD
      • Piqueras, Spanien, 26006
        • Rekruttering
        • START Rioja
        • Ledende efterforsker:
          • Maria Jose de Miguel Luken, MD
        • Kontakt:
      • Seville, Spanien, 41009
        • Rekruttering
        • Hospital Universitario Virgen Macarena
        • Ledende efterforsker:
          • David Vicente Baz, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  1. Signed the informed consent voluntarily and agreed to follow the program requirements

  2. Either sex

  3. Age: ≥18 years

  4. Has a life expectancy of ≥3 months

  5. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: NSCLC, HER2 - breast cancer, esophageal cancer, SCLC, NPC, and HNSCC.

    Has documented locally advanced or metastatic HER2 negative (by immunohistochemistry [IHC], score of 0 or 1) Hormone Receptor (HR) positive (HER2-, HR+) OR HER2 negative (IHC score of 0 to 2) HR negative breast cancer (HER2-, HR-) as per ASCO CAP criteria (ASCO CAP 2023; Wolff et al. 2023), not amenable to curative surgery or radiation with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease, must have received 1 prior line of chemotherapy for advanced disease and, when applicable and if approved in that region, a PD-1/PD-L1 inhibitor, either given concurrently or sequentially. When appropriate, must have progression on at least 1 prior line of hormonal therapy with or without a targeted therapy (such as CDK4/6, mTOR, or PI3-K inhibitors) administered for treatment of metastatic disease.

    In Dose Escalation and Dose finding portions of the study, for triple-negative breast cancer (TNBC, HER2-/HR-) participants must have received PARP inhibitors if a BRCA mutation is present and sacituzumab govitecan as second line treatment. Participants who are HER2 low must have received trastuzumab deruxtecan.

  6. Agree to provide archived tumor samples (tissue block or slides) from primary or metastatic sites within 2 years. In the event that no archival tissue is available a fresh tissue biopsy is highly encouraged but not mandatory.

  7. Has at least one measurable lesion based on RECIST V1.1 (with the exception of Prostate adenocarcinoma cohort, where subjects with bone metastasis are allowed)

  8. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1

  9. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)

  10. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%

  11. Has adequate organ function before registration, defined as: a) Marrow Function: Absolute neutrophil count (ANC) ≥1.2×109 /L, Platelet count ≥100×109 /L, Hemoglobin (Hb) ≥90 g/L b) Hepatic function: Total bilirubin（TBIL≤1.5 ULN, AST and ALT without liver metastasis ≤2.5 ULN, AST and ALT with liver metastasis ≤5.0 ULN c) Renal function: Creatinine clearance ≥50 mL/min (According to the Cockcroft and Gault equation)

  12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN

  13. Urinary protein ≤2+ or ≤1000mg/24 hours

  14. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months for females and 4 months for males after the last dose of study treatment. An additional contraceptive method, such as a barrier method like a condom is required.

  15. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman >45 years old in the absence of other biological or physiological causes. In addition, females <55 years old must have a serum follicle stimulating hormone (fsh) level > 40 mIU/mL to confirm menopause.

  16. For subjects with NSCLC (EGFR mutation):

    a) Evidence of documented EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R), the serine-isoleucine mutation in EGFR Exon 20 (ex20S768I), the leucine-glutamine substitution mutation in Exon 21 (ex21L861Q), or the glycine substitution (with alanine, cysteine, or serine) mutation in Exon 18 (ex18G719X) at or after the time of disease diagnosis and prior to initiation of treatment.

  17. For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):

    a) Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC

  18. For Esophageal adenocarcinoma

    a) Has locally advanced or metastatic adenocarcinoma cell carcinoma of the esophagus or esophagogastric junction cancers, not amenable to curative surgery or radiation with documentation of radiological disease progression after one line of fluoropyrimidine and/or platinum-based chemotherapy treatment regimen for locally advanced or metastatic disease.

    NOTE: Prior therapies such as trastuzumab, zolbetuximab, or IOs are allowed in the study.

  19. For Prostate adenocarcinoma

    a) Subject has metastatic castration-resistant prostate cancer (mCRPC) after progression on/after an androgen receptor pathway inhibitors (ARPI) treatment, such as abiraterone, enzalutamide, apalutamide and darolutamide.

    Note: No prior chemotherapy including docetaxel is allowed Prior treatment with lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is allowed. Enrollment will be capped for lutetium Lu 177 vipivotide tetraxetan-naive participants at approximately 20 or participants with prior lutetium Lu 177 vipivotide tetraxetan treatment at approximately 20.

  20. For NSCLC (EGFR wild type) with squamous histology

    1. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease with predominantly squamous cell histology
    2. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).
    3. Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1/L1 monoclonal antibody given either concurrently or sequentially.

  21. For NSCLC (EGFR wild type) with adenocarcinoma histology

    1. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease with predominantly adenocarcinoma histology
    2. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).

    Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1/L1 monoclonal antibody given either concurrently or sequentially.

  22. Ovarian adenocarcinoma

    a) Has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous platinum-containing chemotherapy with or without a PARP inhibitor.

    Note: participants with platinum-sensitive or platinum resistant recurrent ovarian cancer (PSR) are eligible. However, enrollment will be capped for platinum-sensitive or platinum resistant participants at approximately 20 each.

    Prior bevacizumab treatment is allowed.

  23. Endometrial carcinoma

    a) Has relapsed, advanced and/or metastatic endometrial carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment

  24. For Cervical carcinoma Has relapsed, advanced and/or metastatic cervical carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment

Exclusion criteria:

  1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration

  2. Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc;

  3. Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block

  4. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)

  5. Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection

  6. Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg)

  7. Participants have Grade 3 lung disease defined according to NCI-CTCAE v5.0, a history of interstitial lung disease (ILD)/ pneumonitis

  8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening; Infusion set-related thrombosis is excluded

  9. Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and/or carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Participants on low dose corticosteroids (<20 mg prednisone or equivalent/day) may participate.

  10. Participants who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-B01D1

  11. Participants have a history of autologous or allogeneic stem cell transplantation (Allo-HSCT)

  12. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2

  13. Participants with ≥ Grade 2 hypokalemia (low concentration of potassium in the blood) according to CTCAE v5.0 (Grade 1: participant asymptomatic with potassium levels <LLN - 3.0 mmol/L or equivalent)

  14. Known Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active Hepatitis B virus infection (HBV-DNA copy number> the lower limit of detection) or active Hepatitis C virus infection (HCV antibody positive and HCV-RNA > the lower limit of detection)

  15. Participants with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis.

  16. Received an investigational drug within 4 weeks, or two half-lives (whichever is longer) prior to first dose of study treatment

  17. Participants who are pregnant or breastfeeding

  18. Other conditions that the investigator believes may make the subject not suitable for participating in this clinical trial.

  19. Participants who have received prior therapy with any ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload (all dose expansion cohorts with exception of TNBC noted below).

    Note: For TNBC dose expansion cohort, participants with prior ADC therapy targeting HER3 and EGFR or a topoisomerase I inhibitor, such as sacituzumab govitecan may be enrolled with Sponsor consultation prior to enrollment

  20. For NSCLC EGFRmut:

    1. Participants treated with more than two systemic chemotherapies prior to randomization.

      NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior systemic chemotherapy

    2. Previously documented EGFR Exon 20 insertion mutations as primary EGFR mutations

  21. For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):

    a) Participants treated with more than two systemic chemotherapies prior to randomization.

    NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior systemic chemotherapy

  22. For Esophageal Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy therapy for locally advanced or metastatic disease. NOTE: this limit only applies to prior systemic chemotherapy.

  23. For Prostate adenocarcinoma:

    a) Prior treatment with systemic chemotherapy.

  24. For NSCLC with EGFR WT squamous or adenocarcinoma histology: a) Participants received more than 1 prior line of systemic chemotherapy for locally advanced or metastatic disease

  25. For Ovarian Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.

  26. For Endometrial Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.

  27. For Cervical Carcinoma a) if received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy.

Notes: Re-treatment with platinum-based chemotherapy is considered one line of therapy.

Note: A participant who does not meet this exclusion criterion may be allowed into the study pending the sponsor's approval, based on current accrual within this dose expansion cohort.

Note: There is no limit on the number of prior lines of non-chemotherapy regimens. ADCs with cytotoxic payloads are considered a line of chemotherapy. For any expansion cohorts, if only limited number of patients can be enrolled with 1 prior line of chemotherapy, the Sponsor has the option to allow participants with more than 1 prior line of chemotherapy to be enrolled, upon Sponsor's approval.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: BL-B01D1 administered Day 1 and Day 8 per cycle

BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
Medicin: BL-B01D1

BL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen
Eksperimentel: BL-B01D1 administered Day 1 per cycle

BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
Medicin: BL-B01D1

BL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants with Dose-limiting toxicities
Tidsramme: One year

Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes:

Hematological toxicities:

  • Grade 4 neutrophil count decreased lasting >7 days
  • Grade ≥3 febrile neutropenia
  • Grade ≥3 platelet count decreased with clinically significant hemorrhage.

Non-Hematological toxicities:

  • Death
  • Hy's law cases
  • Grade ≥3 non-hematological toxicities,
One year
Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs),
Tidsramme: One year

Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
One year
Participants with abnormal physical examination findings
Tidsramme: One year

Measure the number of participants with abnormal physical examination findings.
One year
Participants with ability to care for themselves, daily activity, and physical activity
Tidsramme: One year

Measure the change in participants with Eastern Clinical Oncology Group (ECOG) Scale of Performance Status. The scale is 0-4 with 0 being the fully active (best outcome) and 4 being completely disabled (worst outcome)
One year
Participants with abnormal ECG reading
Tidsramme: One year

Measure the number of participants with abnormal ECG parameters
One year
Participants with abnormal lab results
Tidsramme: One year

Measure the number of participants with abnormal clinical laboratory values
One year
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and two or more recommended doses and schedules for recommended dose expansion (RDEs) of BL-B01D1 in metastatic NSCLC
Tidsramme: One year

Determine the highest BL-B01D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-B01D1 dose administered in the event and MTD cannot be defined.
One year

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cmax of BL-B01D1
Tidsramme: One year

Calculate maximum (peak) observed concentration of BL-B01D1
One year
Cmax of anti-EGFR×HER3 antibody
Tidsramme: One year

Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody
One year
Cmax of free payload ED-04
Tidsramme: One year

Calculate maximum (peak) observed concentration of free payload ED-04
One year
Tmax of BL-B01D1
Tidsramme: One year

Calculate time of maximum observed concentration of BL-B01D1
One year
Tmax of anti-EGFR×HER3 antibody
Tidsramme: One year

Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody
One year
Tmax of free payload ED-04
Tidsramme: One year

Calculate time of maximum observed concentration of free payload ED-04
One year
AUC(0-8) of BL-B01D1
Tidsramme: One year

Calculate area under the serum concentration-time curve of BL-B01D1 from time 0 to 8 hours
One year
AUC(0-8) of anti-EGFR×HER3 antibodies
Tidsramme: One year

Calculate area under the serum concentration-time curve of anti-EGFR×HER3 antibodies from time 0 to 8 hours
One year
AUC(0-8) of free payload ED-04
Tidsramme: One year

Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours
One year
AUC(last) of BL-B01D1
Tidsramme: One year

Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time
One year
AUC(last) anti-EGFR×HER3 antibodies
Tidsramme: One year

Calculate area under the serum concentration-time curve up of anti-EGFR×HER3 antibodies to the last quantifiable time
One year
AUC(last) of free payload ED-04
Tidsramme: One year

Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time
One year
Overall Response Rate (ORR)
Tidsramme: One year

To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1
One year
Disease Control Rate (DCR)
Tidsramme: One year

To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1
One year
Time To Response (TTR)
Tidsramme: One year

To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1
One year
Progression-Free Survival (PFS),
Tidsramme: One year

To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1
One year
Overall Survival (OS).
Tidsramme: One year

To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1
One year
Antitumor Activity
Tidsramme: One year

To investigate the antitumor activity of BL-B01D1 as evaluated using RECIST Version 1.1
One year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
SystImmune Inc.

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studieleder: Jimmy Zhao, MD, PhD, SystImmune Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
8. august 2023

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
20. april 2030

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
22. juli 2030

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
12. juli 2023

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
1. august 2023

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
9. august 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
15. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • BL-B01D1-LUNG-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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