이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

전이성 또는 절제 불가능한 비소세포폐암(NSCLC) 환자에서 BL-B01D1을 평가하기 위한 연구

2026년 9월 15일 업데이트: SystImmune Inc.

전이성 또는 절제 불가능한 비소세포폐암 환자에서 BL-B01D1의 안전성, 내약성 및 효능을 평가하는 1상 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

540

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
의약품: BL-B01D1

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

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

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Participants with Dose-limiting toxicities
기간: 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),
기간: 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
기간: 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
기간: 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
기간: One year

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

2차 결과 측정

결과 측정
측정값 설명
기간
Cmax of BL-B01D1
기간: One year

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

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

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

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

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

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

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

SystImmune Inc.

수사관

  • 연구 책임자: Jimmy Zhao, MD, PhD, SystImmune Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 8월 8일

기본 완료 (추정된)

2030년 4월 20일

연구 완료 (추정된)

2030년 7월 22일

연구 등록 날짜

최초 제출

2023년 7월 12일

QC 기준을 충족하는 최초 제출

2023년 8월 1일

처음 게시됨 (실제)

2023년 8월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BL-B01D1-LUNG-101

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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