What is BL-B01D1 studying for gynecological and other solid tumors?

BL-B01D1 is being studied to understand its safety, how the body processes it, and how well it works in treating multiple solid tumors, including recurrent or metastatic gynecological cancers. This research evaluates the drug's effects and appropriate dosing to help patients with these conditions. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd.

Who may be eligible for this gynecological malignancies clinical trial?

Adults aged 18 to 75 with recurrent or metastatic gynecological cancers that have not responded to standard treatments may be eligible. Participants must have a good general health status and normal heart function, among other criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this gynecological malignancies clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID05803018

Study of BL-B01D1 Injection for Treating Multiple Solid Tumors Including Recurrent or Metastatic Gynecological Cancers in Adults

Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of BL-B01D1, an intravenous drug, in patients with multiple solid tumors, including recurrent or metastatic gynecological cancers. This phase IbII clinical study aims to find the recommended dose for further trials and assess the drugs initial effects and immune response in these patients. Participants receive BL-B01D1 by intravenous infusion during the first 3-week treatment cycle. Patients who show clinical benefit may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons for stopping treatment occur. The study includes two phases Phase Ib focuses on safety and dose finding, while Phase II explores efficacy at the recommended dose. During the study, researchers will monitor participants for treatment effects, side effects, and how the drug behaves in the body. They will collect tumor tissue samples, measure tumor response, and assess survival indicators for up to about 24 months. Safety monitoring includes evaluating adverse events and immune reactions. Participants will be followed regularly to assess treatment outcomes and overall health throughout the study period.

CONDITIONS

Brief Title

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Voluntarily sign informed consent and follow study rules
Aged 18 to 75 years
Expected survival time of at least 3 months
Histologically or cytologically confirmed recurrent or metastatic gynecological malignancies with prior treatment failure, intolerance, or no current standard treatment
Agree to provide archived or fresh tumor tissue samples from the past 3 years
At least one measurable tumor lesion per RECIST v1.1
ECOG performance status score of 0 or 1
Side effects from previous cancer therapy recovered to Grade 1 or less
No severe cardiac dysfunction with left ventricular ejection fraction of 50% or higher
Adequate organ function without recent transfusions or growth factor treatments
Coagulation function with INR ≤1.5 and APTT ≤1.5 times upper limit of normal
Urine protein ≤2+ or ≤1000 mg/24h
For premenopausal women with childbearing potential, negative pregnancy test and agreement to use contraception during and 6 months after treatment

You will not qualify if you...

Received chemotherapy, biological therapy, immunotherapy, or other anticancer treatments within 4 weeks or 5 half-lives prior to first dose (6 weeks for certain drugs)
History of severe heart disease
Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia
Active autoimmune or inflammatory diseases
Other progressing or recently treated malignancies within 5 years
Poorly controlled hypertension despite two medications
Poorly controlled blood glucose levels
History or suspicion of interstitial lung disease
Significant pulmonary disease causing respiratory impairment
Unstable thrombotic events within 6 months before screening
Central nervous system metastases or carcinomatous meningitis
Significant or uncontrolled serous cavity effusion
Hypersensitivity to recombinant humanized antibodies or BL-B01D1 components
Tumor invasion or encasement of major blood vessels
Previous organ or stem cell transplantation
High cumulative prior anthracycline dose
Positive for HIV, active tuberculosis, or active hepatitis B or C infections
Severe infection within 4 weeks before first dose
Participation in another clinical trial within 4 weeks before first dose
Any other condition judged unsuitable by the investigator

Research Team

Sa Xiao, PHD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study of BL-B01D1 Injection for Treating Multiple Solid Tumors Including Recurrent or Metastatic Gynecological Cancers in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria