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COMPLETED
NCT06139536
PHASE1

Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients

Sponsor: Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

This is a Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT4706 Injection Combined With BAT1308 Injection in Patients With Advanced Solid Tumors.

Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT4706 Injection Combined With BAT1308 Injection in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-03-06

Completion Date

2026-03-17

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

BAT4706 Injection

Intravenous infusion, 3 weeks one cycle(Q3W), Administer on the first day of each cycle. In the first four cycles, administration starting with BAT1308, and then administering BAT4706 on the same day. Maintain administration of BAT1308 monotherapy after four cycles.

DRUG

BAT1308 Injection

Intravenous infusion, 3 weeks one cycle(Q3W), Administer on the first day of each cycle. In the first four cycles, administration starting with BAT1308, and then administering BAT4706 on the same day. Maintain administration of BAT1308 monotherapy after four cycles.

Locations (3)

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China

Linyi Cancer Hospital

Linyi, Shandong, China