NCT06220318

Assessment of the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors

A Phase I/II Clinical Study on the Safety, Tolerability and Preliminary Efficacy of C019199 in Combination With Sintilimab in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Fujian Haixi Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II non-randomized, open-label, single-arm, multicenter study to evaluate the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors.

Detailed description

Phase I will determine and confirm the maximum tolerated dose(MTD) and recommended phase II dose(RP2D) for C019199 in combination with 200 milligrams (mg) ( intravenous\[IV\], every 3 weeks \[Q3W\]) Sintilimab in patients with advanced Solid tumors. Phase II will evaluate the safety and efficacy of the combination of C019199 and Sintilimab in selected solid tumors at the RP2D from Phase I.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	C019199	The C019199 will be taken orally, once a day
DRUG	Sintilimab	Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.

Timeline

• Start date: 2023-07-19
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2024-01-23
• Last updated: 2025-11-28

Locations

2 sites across 1 country: China