NCT06410703

CAN1012 Combined With PD-1 in Patients With Solid Tumors

A Phase Ib/IIa, Dose Escalation, Open-Label Study of Intratumoral CAN1012 Combined With PD-1 in Patients With Unresectable or Metastatic Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Canwell Biotech Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ia/IIb, open-label, first-in-human, multicenter, single-arm, dose escalation study of intratumoral CAN1012 combined with PD-1 in patients with Unresectable or Metastatic Advanced Solid Tumors who have exhausted options for standard of care therapy.

Detailed description

The scope of the study is to evaluate the safety of the combination therapy of CAN1012 and PD-1 in human, study its efficacy and pharmacokinetics profiles, as well as explore its pharmacodynamic effects and biomarkers.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CAN1012	CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-05-30
• Completion: 2026-05-30
• First posted: 2024-05-13
• Last updated: 2024-10-31

Locations

1 site across 1 country: China