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RECRUITING
NCT07697443
PHASE1/PHASE2

Clinical Trial of TQB3126 for Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Breast Cancer Subjects

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

The study includes Phase I dose escalation and expansion and Phase II combination therapy. It uses a multicenter, open-label, non-randomized design to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3126 in breast cancer. Phase I dose escalation uses a Rolling 6 design after accelerated titration at the first dose, with dose decisions reviewed by the Safety Review Committee. Dose expansion includes two cohorts of approximately 20-60 participants each. The study also explores relationships between drug exposure and efficacy/safety, including concentration-QTc assessment using Holter electrocardiograms.

Official title: Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3126 in Subjects With Breast Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-09-12

Completion Date

2030-08

Last Updated

2026-10-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

TQB3126

TQB3126 is a targeted protein degrader.

Locations (6)

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

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China