BL-B01D1 plus pembrolizumab, with or without bevacizumab, for recurrent or metastatic cervical and endometrial cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + Pembrolizumab Dual Therapy With or Without Bevacizumab (BL-B01D1 + Pembrolizumab ± Bevacizumab) in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer

This trial will try a combination of BL-B01D1 and pembrolizumab, with or without bevacizumab, in adults with recurrent or metastatic cervical or endometrial cancer to see if it shrinks tumors or controls the disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, pembrolizumab, bevacizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07054567 on ClinicalTrials.gov

What this trial studies

This Phase II trial enrolls adults with histologically confirmed recurrent or metastatic cervical or endometrial cancer to receive BL-B01D1 plus pembrolizumab, with some participants also receiving bevacizumab. Patients must have measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ function, and archived tumor tissue for PD-L1 and other testing. The study will monitor tumor responses and safety outcomes while ensuring prior treatment toxicities have recovered. Treatments are administered at a single participating center and patients are followed for efficacy and adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with recurrent or metastatic cervical or endometrial cancer confirmed by pathology, ECOG 0–1, at least one measurable lesion, adequate organ function, available archived tumor tissue, and prior treatment toxicities recovered to ≤ Grade 1 are ideal candidates.

Not a fit: Patients with poor performance status, life expectancy under three months, inadequate organ function, active pregnancy or lactation, or who cannot provide required tumor tissue are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could improve tumor response rates and prolong disease control for patients with recurrent or metastatic cervical or endometrial cancer.

How similar studies have performed: PD‑1 inhibitors and bevacizumab have shown activity in these cancers, but BL-B01D1 is an investigational agent and its combination with pembrolizumab is novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

1. The subject voluntarily participates in this study and signs the informed consent form;
2. Age ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG performance status score of 0-1;
5. Patients with recurrent or metastatic cervical cancer or endometrial cancer confirmed by histopathology and/or cytology;
6. Archived tumor tissue samples from the primary or metastatic lesions within the past 3 years must be provided for PD-L1 and other testing;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Organ function levels must meet the requirements;
9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum or urine pregnancy test must be negative. Patients must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

Exclusion Criteria:

1. Previously received ADC drugs with topoisomerase I inhibitors as the toxin or targeting EGFR and/or HER3;
2. Received chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose;
3. For Stage II (excluding Cohort 1), subjects who have previously received systemic anti-tumor therapy;
4. Prior immunotherapy resulting in ≥ Grade 3 irAE or ≥ Grade 2 immune-related myocarditis;
5. Used immunomodulatory drugs within 14 days before the first dose of the study drug;
6. Required systemic corticosteroid therapy within 2 weeks before the first dose of the study drug;
7. History of severe cardiovascular or cerebrovascular diseases;
8. Active autoimmune or inflammatory diseases;
9. Other malignancies that progressed or required treatment within 3 years before the first dose;
10. History of ILD/pneumonitis requiring steroid treatment, or current ILD/active pneumonitis;
11. Poorly controlled hypertension (requiring ≥ 2 antihypertensive medications);
12. Poorly controlled diabetes;
13. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
14. Active central nervous system metastases;
15. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
16. History of allergy to recombinant humanized antibodies or any excipients of the investigational drug;
17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
18. Positive for HIV antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
19. Active infection requiring systemic treatment;
20. Participation in another clinical trial within 4 weeks before the first dose;
21. Imaging shows tumor invasion or encasement of major abdominal, thoracic, cervical, or pharyngeal blood vessels;
22. Presence of severe unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent;
23. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;
24. Planned or received live vaccines within 28 days before randomization;
25. History of severe neurological or psychiatric disorders;
26. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Cervical Cancer; Endometrial Cancer