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

A Phase III Randomized Controlled Clinical 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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Cancer
• Intervention / Treatment: Drug: BL-M07D1; Drug: Paclitaxel; Drug: Liposomal Doxorubicin; Drug: Topotecan

Detailed Description

In this trial, the treatment group will receive BL-M07D1, while the control group will receive physician's choice of chemotherapy (liposomal doxorubicin, paclitaxel, or topotecan).

• Study Type: Interventional
• Enrollment (Estimated): 404
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Lingying WU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Be ≥18 years and ≤75 years old on the day of signing the informed consent form;
3. Have an expected survival time of ≥3 months;
4. Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
5. Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;
6. Have received a total of ≥1 and ≤3 prior lines of therapy;
7. If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;
8. Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;
9. Have at least one measurable lesion as defined by RECIST v1.1;
10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
11. Have recovered from toxicities of prior anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
12. Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;
13. Meet the required organ function levels;
14. 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.

Exclusion Criteria:

1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;
2. Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;
3. History of severe cardiovascular or cerebrovascular disease within six months before screening;
4. Concurrent pulmonary disease resulting in severely impaired lung function;
5. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
6. Diagnosed with active malignancy within 3 years before study randomization;
7. Unstable thrombotic event requiring therapeutic intervention within 6 months before screening;
8. Hypertension inadequately controlled by two antihypertensive medications;
9. Patients with poorly controlled blood glucose levels;
10. History of ILD treated with steroids, or current ILD, or Grade ≥2 radiation pneumonitis, etc.;
11. Patients with active central nervous system (CNS) metastases;
12. Seizure-free status lasting >12 weeks with or without the use of antiepileptic drugs;
13. No requirement for corticosteroid use to control cerebral edema;
14. Radiographically stable status confirmed by two consecutive MRIs;
15. Patients with a history of allergy to recombinant humanized antibodies or to any excipient of BL-M07D1;
16. Prior receipt of organ transplantation or allogeneic hematopoietic stem cell transplantation;
17. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
18. Experienced severe infection within 4 weeks before the first dose of study drug;
19. Presence of large serosal cavity effusions, or symptomatic serosal cavity effusions, etc.;
20. Receiving long-term systemic corticosteroid therapy (e.g., >10 mg/day prednisone) prior to randomization;
21. History of severe neurological or psychiatric disorders;
22. Experienced serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;
23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
24. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
25. Received other unapproved clinical study drugs or treatments within 4 weeks before study randomization;
26. Subjects who plan to receive or have received a live vaccine within 28 days before the first dose;
27. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for this study in the investigator's opinion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-M07D1; 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; Administration by intravenous infusion for a cycle of 3 weeks.
Active Comparator: physician's choice of chemotherapy; 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: Paclitaxel; Administration by intravenous infusion for a cycle of 4 weeks.; Drug: Liposomal Doxorubicin; Administration by intravenous infusion for a cycle of 4 weeks.; Drug: Topotecan; Administration by intravenous infusion for a cycle of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).	Up to approximately 24 months
Disease Control Rate (DCR)	Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.	Up to approximately 24 months
Duration of Response (DOR)	Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.	Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.	Up to approximately 24 months
Anti-drug antibody (ADA)	Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.	Up to approximately 24 months
Response Rate (RR)	Response Rate (RR) is defined as the proportion of subjects whose overall response is assessed as remission according to the RECIST v1.1 and GCIG CA-125 criteria.	Up to approximately 24 months
CA-125 Response Rate	CA-125 Response Rate is defined as the proportion of subjects who achieve a response according to the GCIG CA-125 criteria.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Organic Chemicals; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Paclitaxel; Topotecan; liposomal doxorubicin
• Other Study ID Numbers: BL-M07D1-308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No