A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor

NCT ID: NCT05262491

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2027-12-31

Brief Summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1.

In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.

Conditions

Gastrointestinal Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study treatment

Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

BL-B01D1

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

BL-B01D1

Administration by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

iza-bren; izalontamab brengitecan; BMS-986507

Eligibility Criteria

Inclusion Criteria

1. Participants must sign the informed consent form voluntarily and follow the plan requirements.

2. No gender limit.

3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib).

4. Expected survival time ≥ 3 months.

5. Patients with locally advanced or metastatic triple-negative breast cancer or other solid tumors who have been diagnosed histopathologically and/or cytologically as failing standard therapy, or who are not eligible for standard therapy at this stage, and who are inoperable.

6. Agree to provide archived tumor tissue samples or fresh tissue samples from the primary tumor or metastatic tumor within 3 years (TROP2 protein expression in tumor pathological tissue to explore the correlation between TROP2 protein expression and BL-M02D1 validity index); If subjects are unable to provide tumor tissue samples, they will be admitted after evaluation by the investigator if other admission criteria are met.

7. Participants must have at least one assessable lesion as defined by RECIST V1.1.

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

9. The toxicity of previous antitumor therapy was restored to ≤1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and elevated blood glucose; Toxicities with no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, were excluded).

10. Has adequate organ function before registration, defined as: a) Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count ≥90×109/L, Hemoglobin ≥90 g/L; B) Hepatic function: Total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN for participants without liver metastasis, AST and ALT ≤5.0 ULN for liver metastases; c) Renal function: Creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to the Cockcroft and Gault formula).

11. Coagulation function: International normalized ratio (INR)≤1.5, and activated partial thromboplastin time (APTT)≤1.5ULN.

12. Urinary protein ≤2+ or ≤1000mg/24h.

13. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating. Adequate barrier contraceptive measures should be taken during the treatment and 6 months after the end of treatment for all participants (regardless of male or female).

Exclusion Criteria

Patients screened for any of the following conditions will not be included in this study:

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

2. Prior treatment with ADC drugs targeting TROP2 or ADC drugs using camptothecin derivatives (topoisomerase I inhibitors) as toxins.

3. 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.

4. Participants with prolonged QT interval (male QTc> 450 msec or female QTc> 470 msec), complete left bundle branch block, III grade atrioventricular block.

5. 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 alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).

6. The presence of a second primary tumor within 5 years prior to initial administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resected carcinoma in situ.

7. Screening for unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within the first 6 months; Infusion device-related thrombosis is excluded;

8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within 6 months prior to screening; Thrombus formation associated with infusion set is excluded.

9. Symptoms of active central nervous system metastasis. However, patients with stable brain parenchymal metastases can be enrolled. Stable was defined as: a. The seizure-free state lasted for > 12 weeks with or without the use of antiepileptic drugs; b. Glucocorticoid use is not required; c. Consecutive MRI scans (at least 8 weeks between scans) showed stable imaging status.

10. Patients with a history of allergy to recombinant humanized antibody or mouse chimeric antibody or to any excipients of BL-B01D1.

11. Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).

12. In previous adjuvant therapy with anthracyclines, the cumulative dose of anthracyclines was > 360 mg/m2.

13. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 103IU/ml) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection).

14. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, septicemia, etc.

15. Participated in another clinical trial (calculated from the time of the last dose) within 4 weeks prior to the first dose.

16. The other conditions of participation in this clinical trial were not considered appropriate by the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SystImmune Inc.

INDUSTRY

Sponsor Role: collaborator

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen, PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Jinan Central Hospital

Jinan, Shandong, China

Site Status: RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+86-15013238943

Facility Contacts

Lin Shen, PHD

Role: primary

doctorshenlin@sina.cn

+86-010-88196561

Li Chen

Role: primary

Meili Sun

Role: primary

Xuelei Ma

Role: primary

Diansheng Zhong

Role: primary

Ji Zhu

Role: primary

References

Liu C, Liu D, Ji Y, Sun M, Gao S, Ma X, Zhong D, Zhu J, Cao Y, Qi C, Zhang M, Zhang P, Xue R, Peng Z, Zhou J, Ge S, Lu M, Yuan J, Wang Y, Wang Z, Li J, Zhang X, Zhu Y, Zhu H, Xiao S, Gong J, Shen L, Lu Z. A bispecific antibody-drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2025 Jul 10. doi: 10.1038/s41591-025-03792-7. Online ahead of print.

Reference Type: DERIVED

PMID: 40640393 (View on PubMed)

Other Identifiers

BL-B01D1-103

Identifier Type: -

Identifier Source: org_study_id