A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

NCT07545460 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-308
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 24 months

• Overall survival (OS)

  Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

  Up to approximately 24 months

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Response Rate (RR)

  Up to approximately 24 months

• CA-125 Response Rate

  Up to approximately 24 months

Study Arms (2)

BL-M07D1

EXPERIMENTAL

Participants receive BL-M07D1 in 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.

Drug: BL-M07D1

physician's choice of chemotherapy

ACTIVE COMPARATOR

Participants receive liposomal doxorubicin, paclitaxel or topotecan in the first cycle (4 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.

Drug: Liposomal Doxorubicin; Drug: Paclitaxel; Drug: Topotecan

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

Liposomal Doxorubicin DRUG

Administration by intravenous infusion for a cycle of 4 weeks.

physician's choice of chemotherapy

Paclitaxel DRUG

Administration by intravenous infusion for a cycle of 4 weeks.

physician's choice of chemotherapy

Topotecan DRUG

Administration by intravenous infusion for a cycle of 4 weeks.

physician's choice of chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Be ≥18 years and ≤75 years old on the day of signing the informed consent form;
• Have an expected survival time of ≥3 months;
• Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
• Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;
• Have received a total of ≥1 and ≤3 prior lines of therapy;
• If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;
• Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;
• Have at least one measurable lesion as defined by RECIST v1.1;
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Have recovered from toxicities of prior anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;
• Meet the required organ function levels;
• For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, with a negative result, and must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.

You may not qualify if:

• Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;
• Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;
• History of severe cardiovascular or cerebrovascular disease within six months before screening;
• Concurrent pulmonary disease resulting in severely impaired lung function;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Diagnosed with active malignancy within 3 years before study randomization;
• Unstable thrombotic event requiring therapeutic intervention within 6 months before screening;
• Hypertension inadequately controlled by two antihypertensive medications;
• Patients with poorly controlled blood glucose levels;
• History of ILD treated with steroids, or current ILD, or Grade ≥2 radiation pneumonitis, etc.;
• Patients with active central nervous system (CNS) metastases;
• Seizure-free status lasting \>12 weeks with or without the use of antiepileptic drugs;
• No requirement for corticosteroid use to control cerebral edema;
• Radiographically stable status confirmed by two consecutive MRIs;
• Patients with a history of allergy to recombinant humanized antibodies or to any excipient of BL-M07D1;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

liposomal doxorubicin; Paclitaxel; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)