Phase I Study of IMM2510 and IMM27M Combination Therapy for Advanced Solid Tumors Including Breast Cancer and Liver Cancer

What this Trial Is About

Researchers are evaluating the combination of IMM2510, an anti-PD-L1VEGF bispecific antibody fusion protein, and IMM27M, a humanized Fc-engineered anti-CTLA-4 antibody, in patients with advanced solid tumors. This open-label, multi-center, single-arm Phase I study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of this combination therapy. The study includes patients with various advanced cancers, such as triple-negative breast cancer, hepatocellular carcinoma, and other solid tumors who have failed or are intolerant to prior treatments. The study has two phases a dose escalation phase and a dose expansion phase. In the dose escalation phase, participants receive a single intravenous dose of IMM27M at 3.0 mgkg on day 1, followed by IMM2510 at either 10.0 mgkg or 20.0 mgkg every two weeks after a 4-week interval. In the dose expansion phase, dosing is based on results from the first phase, with patients receiving IMM27M on day 1 and IMM2510 every two weeks. Treatment continues up to a maximum of 48 weeks or until disease progression or other reasons. Participants undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, and immune-related adverse events. Researchers evaluate tumor response using criteria such as progression-free survival and overall survival over approximately two years. Pharmacokinetic measures like maximum concentration and half-life are collected up to one year. Safety follow-up extends up to 30 to 90 days after the last dose, and participants are closely monitored throughout the study duration, expected to last until early 2026.

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