NCT05021367

A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3823 Tablets in Subjects With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AEs) and serious adverse events (SAEs) , pharmacokinetic parameters and antitumor effect of TQB3823 tablets in Chinese adult patients with advanced solid tumors .The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3823 tablets, determine MTD;Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TQB3823 tablets	TQB3823 is a small molecule Poly ADP-ribose Polymerase (PARP) inhibitor that can inhibit the enzyme activity of PARP1/2, making it difficult to repair the DNA in cancer cells, leading to cell death and delaying or blocking tumor development.

Timeline

• Start date: 2021-09-23
• Primary completion: 2025-02-01
• Completion: 2025-10-01
• First posted: 2021-08-25
• Last updated: 2023-07-24

Locations

1 site across 1 country: China