A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
Trial Parameters
Brief Summary
In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.
Eligibility Criteria
Inclusion Criteria: 1. Participants must sign the informed consent form voluntarily and follow the plan requirements. 2. No gender limit. 3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib). 4. Expected survival time ≥ 3 months. 5. Locally advanced or metastatic solid tumor confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment. 6. Agrees to provide archived tumor tissue specimens or fresh tissue samples from the primary lesion or metastasis within 2 years; If a subject is unable to provide a tumor tissue sample, he/she may be enrolled after being evaluated by the investigator if other inclusion criteria are met. 7. Participants must have at least one measurable lesion that meets the definition of RECIST v1.1. 8. Physical fitness score ECOG 0 or 1 point 9. Toxicity of previous antitumor therapy has returned to ≤ level 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by