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New treatment option for Cervical Cancer
Official title A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer
ClinicalTrials.gov ID: NCT07054567
What this study is testing
What is BL-B01D1?
BL-B01D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
Also referred to as iza-bren, izalontamab brengitecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join 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), people 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;
See the full eligibility criteria
- 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...
- 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), people 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;
- 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);
- Positive for HIV antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
- Active infection requiring systemic treatment;
- Participation in another clinical trial within 4 weeks before the first dose;
- Imaging shows tumor invasion or encasement of major abdominal, thoracic, cervical, or pharyngeal blood vessels;
- 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 neurological or psychiatric disorders;
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.