NCT05508659

A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors

A Multi-centre, Randomized, Open-label, Phase 1/2 Trial to Investigate the Safety, Tolerability, and Preliminary Anti-cancer Efficacy of Duvelisib Combined With SG001 Injection in Advanced Solid Tumours

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study will be conducted with 2 stages.

Detailed description

The first stage will explore the suitable dose of duvelisib when combined with SG001 injection in patients with advanced solid tumors who had failed with prior systemic therapy. The second stage will explore the safety and tolerability, preliminary anti-tumor efficacy and PK data of duvelisib monotherapy and combo regime with SG001 injection in patients with advanced solid tumors which will including but not limited with esophageal carcinoma, gastric carcinoma, colorectal cancer and head and neck squamous carcinoma.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Duvelisib	Duvelisib PR2D bid po. until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.
DRUG	SG001	240mg, each two weeks,iv,until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.

Timeline

• Start date: 2022-09-20
• Primary completion: 2024-09-20
• Completion: 2025-03-20
• First posted: 2022-08-19
• Last updated: 2022-08-19