A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gyn… (NCT05803018) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies
China38 participantsStarted 2023-06-25
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. ECOG performance status score of 0 or 1;
✓. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
Exclusion criteria
✕. 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;
✕. 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;
✕. Poorly controlled blood glucose levels;
✕. History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening;