A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Meta… (NCT06031584) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors
China42 participantsStarted 2024-01-19
Plain-language summary
Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors.
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;
✓. No gender restrictions;
✓. Age: ≥18 years and ≤75 years;
✓. Expected survival time ≥3 months;
✓. Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
✓. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;
✓. Must have at least one measurable lesion as defined by RECIST v1.1;
✓. ECOG performance status score of 0 or 1;
Exclusion criteria
✕. Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
✕. Previously treated with ADC drugs containing camptothecin derivatives as payloads;
✕. History of severe cardiovascular or cerebrovascular diseases;
✕. Active autoimmune or inflammatory diseases;
✕. History of other malignancies within 5 years prior to the first dose;
✕. Thrombotic events requiring therapeutic intervention within 6 months before screening;
✕. Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;