Tests BL-B01D1 with pembrolizumab, with or without bevacizumab, in cervical and endometrial cancer
Tests BL-B01D1 with pembrolizumab in adults with recurrent or spreading cervical or endometrial cancer.
Plain-language title generated from the registry record
Registry title: A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cervical cancer or endometrial cancer that has come back or spread, to test BL-B01D1 with pembrolizumab, with or without bevacizumab.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- Cervical cancer or endometrial cancer that has come back or spread (recurrent or metastatic), confirmed by tissue and/or cell tests. At least one tumour that can be measured on scans (RECIST v1.1).
- Earlier treatment
- Side effects from earlier cancer treatment must have eased to Grade 1 or less. In Stage II (except Cohort 1), people who had earlier whole-body cancer treatment cannot join. People who had certain antibody-drug treatments (topoisomerase I inhibitor toxin, or targeting EGFR and/or HER3) cannot join.
- Biomarker or test result
- Stored tumour tissue from the past 3 years must be provided for PD-L1 and other tests.
Main reasons for not taking part
- Active central nervous system metastases
- Active autoimmune or inflammatory disease
- History of ILD/pneumonitis needing steroids, or current ILD/active pneumonitis
- Organ transplant or allogeneic stem cell transplant before
- Positive for HIV antibody, active tuberculosis, active hepatitis B or active hepatitis C
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07054567, who can take part
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT07054567
- Record updated
- 21 January 2026
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: 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.
Exclusion: 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; Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; History of allergy to recombinant humanized antibodies or any excipients of the investigational drug; Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); Participation in another clinical trial within 4 weeks before the first dose; Presence of severe unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent; Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent; Planned or received live vaccines within 28 days before randomization; 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; Positive for HIV antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection; Active infection requiring systemic treatment; History of severe neurological or psychiatric disorders; Other conditions deemed by the investigator as unsuitable for participation in this clinical trial; Previously received ADC drugs with topoisomerase I inhibitors as the toxin or targeting EGFR and/or HER3; Active central nervous system metastases; Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion; Imaging shows tumor invasion or encasement of major abdominal, thoracic, cervical, or pharyngeal blood vessels.