NCT05803018
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies
Recruiting · Phase 1, Phase 2 · Sichuan Baili Pharmaceutical Co., Ltd. · registry updated 2025-09-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies.
Inclusion
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Histologically and/or cytologically confirmed recurrent or metastatic gynecological malignancies with failed standard treatment, intolerance to standard treatment, or no current standard treatment available;
- Agree to provide archived tumor tissue specimens (10 slides) or fresh tissue samples from primary or metastatic lesions within the past 3 years;
- Must have at least one measurable lesion as defined by RECIST v1.1;
Exclusion
- Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.);
- 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 malignancies with progression or requiring treatment within 5 years prior to the first dose;
- Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg) despite the use of two antihypertensive medications;