NCT06035744

CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

A Phase 1 First-in-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Cullinan Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CLN-617	Single-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences
DRUG	Pembrolizumab	Humanized IgG4 anti-PD-1 monoclonal antibody

Timeline

• Start date: 2023-12-12
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2023-09-13
• Last updated: 2025-03-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study