A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

NCT ID: NCT06031584

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2026-03-31

Brief Summary

Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors.

Conditions

Her2-positive/Low-expression Urinary and Digestive Tract Tumors

Study Design

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

Study Groups

Study treatment

Participants received BL-M07D1 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

Group Type: EXPERIMENTAL

BL-M07D1

Intervention Type: DRUG

BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.

Interventions

BL-M07D1

BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent form and comply with the protocol requirements;

2. No gender restrictions;

3. Age: ≥18 years and ≤75 years;

4. Expected survival time ≥3 months;

5. Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;

6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;

7. Must have at least one measurable lesion as defined by RECIST v1.1;

8. ECOG performance status score of 0 or 1;

9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;

11. Organ function levels must meet the requirements;

12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;

13. Urine protein ≤2+ or ≤1000 mg/24h;

14. Albumin ≥30 g/L;

15. For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.

Exclusion Criteria

1. Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;

2. Previously treated with ADC drugs containing camptothecin derivatives as payloads;

3. History of severe cardiovascular or cerebrovascular diseases;

4. Active autoimmune or inflammatory diseases;

5. History of other malignancies within 5 years prior to the first dose;

6. Thrombotic events requiring therapeutic intervention within 6 months before screening;

7. Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;

8. Poorly controlled hypertension despite antihypertensive medication;

9. Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;

10. Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;

11. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;

12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;

13. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;

14. Active hepatitis B virus (HBV) infection (exclusion criterion);

15. Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;

16. Participation in another clinical trial within 4 weeks before the first dose;

17. Pregnant or lactating women;

18. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

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

Sponsors

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aiping Zhou, PHD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+8615013238943

Facility Contacts

Aiping Zhou, PHD

Role: primary

Other Identifiers

BL-M07D1-202

Identifier Type: -

Identifier Source: org_study_id