臨床研究等提出・公開システム

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects with Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

A Phase 1 Study of BL-B01D1 in Subjects with Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

jRCT IQVIA staffs

IQVIA Services Japan G.K.

4-10-18 Minatoku, Takanawa, Tokyo

JP-BL-B01D1-LUNG-101_team@iqvia.com

jRCT IQVIA staffs

IQVIA Services Japan G.K.

4-10-18 Minatoku, Takanawa, Tokyo

+81-3-6859-9500

JP-BL-B01D1-LUNG-101_team@iqvia.com

Recruiting

April. 30, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Sign informed consent
2.Expected survival > or = 3months
3. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer, and HNSCC
4. Agree to provide a tumor sample
5. Has at least one measurable lesion based on RECIST 1.1
6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
7. 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.)
8. Has no serious cardiac dysfunction, left ventricular ejection fraction >=50%.
9. Has adequate organ function before registration
10. Coagulation function: international normalized ratio (INR) <=1.5xULN, and activated partial thromboplastin time (APTT) <=1.5 ULN
11. Urinary protein <=2+ or <=1000mg/24 hours
12. 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 after the last dose of study treatment
13. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating

1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy and other anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration
2. Subjects with history of severe heart disease
3. Active autoimmune diseases and inflammatory diseases
4. Other malignant tumors were diagnosed within 5 years
5. Subjects with poorly controlled hypertension
6. Subjects have Grade 3 lung disease or a history of interstitial lung disease
7. Subjects with stroke (including transient ischemic attack [TIA]), myocardial infarction, or other ischemic event or thromboembolic event (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months before randomization
8. Symptoms of active central nervous system metastasis
9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
10. Subjects have a history of autologous or allogeneic stem cell transplantation
11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
12. Subjects with active infections requiring systemic treatment
13. Participated in another clinical trial within 4 weeks prior to participating in the study
14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
15. Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block
16. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2

Both

Non-Small Cell Lung Cancer and Other Solid Tumors

Cohort A: Beginning with Cycle 1, BL-B01D1 will be administered on Day 1 and Day 8 by intravenous (IV) infusion every 3 weeks (D1D8, Q3W)
Cohort B: Beginning with Cycle 1, BL-B01D1 will be administered on Day 1 by IV infusion every 3 weeks cycles (D1Q3W)

- Dose-limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), physical examination findings (including ECOG performance status [PS]), vital sign measurements, standard clinical laboratory parameters, ECG parameters, and ECHO/MUGA findings.
- MTD, MAD, and RDE

+81-3-3542-2511

Mar. 03, 2025

No

United States/Spain/France/Italy