OncRef

Clinical Trial: NCT05194982

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:Sichuan Baili Pharmaceutical Co., Ltd.
Information Provided By:Sichuan Baili Pharmaceutical Co., Ltd.
Last Update Posted:2026-08-27

Study Overview

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.

Official Title

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

Conditions

Locally Advanced or Metastatic Solid Tumor

Intervention / Treatment

  • Drug: BL-B01D1

Other Study ID Numbers

  • BL-B01D1-101

Start Date (Actual)

2021-11-29

Primary Completion Date (Estimated)

2026-12

Study Completion Date (Estimated)

2027-12

Enrollment (Estimated)

570

Study Type

Interventional

Phase

Phase 1