A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer

NCT07054567 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-204-11
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II study is a clinical trial 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.

Conditions

Cervical Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.

  Up to approximately 24 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

BL-B01D1 + pembrolizumab ± bevacizumab

EXPERIMENTAL

Participants receive BL-B01D1 + pembrolizumab ± bevacizumab 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-B01D1; Drug: Pembrolizumab; Drug: Bevacizumab

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1 + pembrolizumab ± bevacizumab

Pembrolizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1 + pembrolizumab ± bevacizumab

Bevacizumab DRUG

Administration for a cycle of 3 weeks.

BL-B01D1 + pembrolizumab ± bevacizumab

Eligibility Criteria

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

You may qualify if:

• The subject voluntarily participates in this study and signs the informed consent form;
• Age ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• ECOG performance status score of 0-1;
• Patients with recurrent or metastatic cervical cancer or endometrial cancer confirmed by histopathology and/or cytology;
• Archived tumor tissue samples from the primary or metastatic lesions within the past 3 years must be provided for PD-L1 and other testing;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Organ function levels must meet the requirements;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• 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.

You may not qualify if:

• Previously received ADC drugs with topoisomerase I inhibitors as the toxin or targeting EGFR and/or HER3;
• Received chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose;
• For Stage II (excluding Cohort 1), subjects who have previously received systemic anti-tumor therapy;
• Prior immunotherapy resulting in ≥ Grade 3 irAE or ≥ Grade 2 immune-related myocarditis;
• Used immunomodulatory drugs within 14 days before the first dose of the study drug;
• Required systemic corticosteroid therapy within 2 weeks before the first dose of the study drug;
• History of severe cardiovascular or cerebrovascular diseases;
• Active autoimmune or inflammatory diseases;
• Other malignancies that progressed or required treatment within 3 years before the first dose;
• History of ILD/pneumonitis requiring steroid treatment, or current ILD/active pneumonitis;
• Poorly controlled hypertension (requiring ≥ 2 antihypertensive medications);
• Poorly controlled diabetes;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Active central nervous system metastases;
• Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

pembrolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 8, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)