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Estudo para avaliar BL-B01D1 em pacientes com câncer de pulmão de células não pequenas (NSCLC) metastático ou irressecável

15 de setembro de 2026 atualizado por: SystImmune Inc.

Um estudo de fase 1 avaliando a segurança, tolerabilidade e eficácia de BL-B01D1 em indivíduos com câncer de pulmão de células não pequenas metastático ou irressecável

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

540

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Medicamento: BL-B01D1

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

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

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Participants with Dose-limiting toxicities
Prazo: 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),
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: One year

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Cmax of BL-B01D1
Prazo: One year

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

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

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

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

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

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

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

SystImmune Inc.

Investigadores

  • Diretor de estudo: Jimmy Zhao, MD, PhD, SystImmune Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de agosto de 2023

Conclusão Primária (Estimado)

20 de abril de 2030

Conclusão do estudo (Estimado)

22 de julho de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

12 de julho de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de agosto de 2023

Primeira postagem (Real)

9 de agosto de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BL-B01D1-LUNG-101

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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