A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

NCT ID: NCT06131450

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2027-12-31

Brief Summary

This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.

Conditions

Gynecological Malignancies

Study Design

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

Study Groups

BL-M07D1

Participants receive BL-M07D1 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-M07D1

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

BL-M07D1

Administration by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Female;

3. Age: ≥18 years old and ≤75 years old;

4. Expected survival time ≥3 months;

5. patients with recurrent or metastatic HER2-positive/low-expression gynecologic malignancies who have failed or are intolerant to standard treatment or who currently have no standard treatment;

6. The histopathology of gynecological malignant tumors should meet the following conditions: HER2 positive; Low expression of HER2;

7. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;

8. At least one measurable lesion meeting the RECIST v1.1 definition was required;

9. ECOG score 0 or 1;

10. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;

11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

12. No blood transfusion, use of any cell growth factors and/or platelet-raising drugs were allowed within 14 days before screening, and the organ function level had to be acceptable;

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

14. albumin ≥30 g/L;

15. Women who are likely to give birth must have negative serum/urine pregnancy within 7 days before treatment and must be non-lactating; All enrolled patients should have adequate contraception throughout the treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria

1. had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;

2. had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;

3. had a history of serious cardiovascular and cerebrovascular diseases;

4. active autoimmune or inflammatory diseases;

5. Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer and prostate/cervix/breast cancer in situ;

6. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening;

7. patients with massive or symptomatic effusions or poorly controlled effusions;

8. Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);

9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;

10. patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases);

11. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1;

12. patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

13. HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;

14. active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;

15. had participated in another clinical trial within 4 weeks before the first dose;

16. pregnant or lactating women;

17. The investigator did not consider it appropriate to apply other criteria for participation in the trial.

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

Sponsors

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

Lingying Wu, 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

Lingying Wu

Role: primary

Other Identifiers

BL-M07D1-203

Identifier Type: -

Identifier Source: org_study_id