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RECRUITING
NCT05461768
PHASE1

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 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-M07D1 in patients

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M07D1injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expression Breast Cancer and Other Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2022-08-09

Completion Date

2027-12

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

DRUG

BL-M07D1

Administration by intravenous infusion

Locations (7)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangdong, Guangzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Jinan Central Hospital

Jinan, Shandong, China

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China