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Studio per valutare BL-B01D1 in pazienti con carcinoma polmonare non a piccole cellule metastatico o non resecabile (NSCLC)

15 settembre 2026 aggiornato da: SystImmune Inc.

Uno studio di fase 1 che valuta la sicurezza, la tollerabilità e l'efficacia di BL-B01D1 in soggetti con carcinoma polmonare non a piccole cellule metastatico o non resecabile

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

540

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: BL-B01D1

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

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

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants with Dose-limiting toxicities
Lasso di tempo: 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),
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: One year

Measure the number of participants with abnormal ECG parameters
One year
Participants with abnormal lab results
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cmax of BL-B01D1
Lasso di tempo: One year

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

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

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

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

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

Calculate time of maximum observed concentration of free payload ED-04
One year
AUC(0-8) of BL-B01D1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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),
Lasso di tempo: 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).
Lasso di tempo: One year

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SystImmune Inc.

Investigatori

  • Direttore dello studio: Jimmy Zhao, MD, PhD, SystImmune Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 agosto 2023

Completamento primario (Stimato)

20 aprile 2030

Completamento dello studio (Stimato)

22 luglio 2030

Date di iscrizione allo studio

Primo inviato

12 luglio 2023

Primo inviato che soddisfa i criteri di controllo qualità

1 agosto 2023

Primo Inserito (Effettivo)

9 agosto 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BL-B01D1-LUNG-101

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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