NCT06139536

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT4706 injection combined with BAT1308 injection in patients with advanced solid tumors, explore the maximum tolerable dose. The study is generally divided into two stages. In the first stage, the "3+3" dose increasing rule is proposed to explore the safety and tolerability, subject will be given BAT1308 injection and BAT4706 injection through Intravenous infusion in the first four cycles, and then maintain administration of BAT1308 monotherapy after four cycles until 18 cycles; In the second stage, based on the preliminary safety and efficacy results of the previous stage, appropriate doses and tumor types were selected for extended research, in order to further explore the safety and clinical effectiveness of BAT4706 injection and BAT1308 injection in the combined administration mode.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2023-11-18
• Last updated: 2024-03-13

Locations

3 sites across 1 country: China