NCT05833984

Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

A Phase 1b/2 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 309 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.

Detailed description

This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part. In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.

Conditions

• Solid Tumor
• Classic Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	IMM01	IMM01 (1.0, 1.5, 2.0 mg/kg) QW IV in the dose escalation part. IMM01 (dose determined in the dose escalation part) QW IV in the dose expansion part.
DRUG	Tislelizumab	Tislelizumab 200mg Q3W IV

Timeline

• Start date: 2022-05-17
• Primary completion: 2024-02-07
• Completion: 2024-11-20
• First posted: 2023-04-27
• Last updated: 2023-04-27

Locations

5 sites across 1 country: China