NCT06764836

A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors

An Open-Label, Multi-Centre, Single-Arm, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of IMM2510 in Combination With IMM27M in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy in patients with advanced solid tumors.

Detailed description

Dose Escalation Phase: 3+3 Dose escalation design of IMM27M + IMM2510 combination therapy in advanced solid tumors. Dose Expansion Phase: Recommended dose for expansion (RDE) of IMM27M + IMM2510 combination therapy in three cohorts: cohort 1: locally advanced unresectable or metastatic triple-negative breast cancer (those with at least first-line systemic treatment failure or intolerance); cohort 2: advanced hepatocellular carcinoma (patients with at least first-line systemic therapy failure or intolerance); cohort 3: other advanced solid tumors (those with at least first-line systemic treatment failure or intolerance).

Conditions

• Advanced Solid Tumors
• HCC

Interventions

Type	Name	Description
DRUG	IMM27M	Intravenous injection
DRUG	IMM2510	Intravenous injection

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-01-27
• Completion: 2026-01-27
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: China