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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer (NCT07054567) is a Phase 2 interventional studying Cervical Cancer and Endometrial Cancer, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cervical Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 96 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cervical Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The subject voluntarily participates in this study and signs the willing to sign a consent form 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. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Pembrolizumab

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Bevacizumab

Administration for a cycle of 3 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07054567), the sponsor (Sichuan Baili Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07054567 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07054567?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07054567?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07054567. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07054567. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.