Clinical trialPhase 1Recruiting
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 14 February 2022
- Expected end
- December 2027
- Enrollment
- 96 participants
- Sites
- 6
- Primary outcomes
- Phase Ia: Dose limiting toxicity (DLT); Phase Ia: Maximum tolerated dose (MTD); Phase Ib: Recommended Phase II Dose (RP2D)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 27 August 2026
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Brief summary public domain (ClinicalTrials.gov)
In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other 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 gastrointestinal tumor and other solid tumor will be evaluated.