Trials / Recruiting
RecruitingNCT05194982
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic 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 Solid Tumor
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-B01D1 | Administration by intravenous infusion. |
Timeline
- Start date
- 2021-11-29
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2022-01-18
- Last updated
- 2025-09-26
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05194982. Inclusion in this directory is not an endorsement.