Phase II Study of HRS-4642 Combined with Nimotuzumab and Chemotherapy for First-Line Treatment of Advanced Pancreatic Cancer with KRAS G12D Mutation

What this Trial Is About

Researchers are studying advanced pancreatic cancer patients with a specific KRAS G12D mutation to evaluate the effectiveness of a treatment combining HRS-4642 with nimotuzumab and chemotherapy. This phase II clinical study includes patients with metastatic or locally advanced pancreatic cancer and aims to assess the response rate and survival outcomes. The study uses a Simon two-stage design to evaluate safety and efficacy early and decide on further enrollment. Participants receive HRS-4642, an intravenous KRAS G12D inhibitor, combined with nimotuzumab, a monoclonal antibody targeting EGFR, and the AG chemotherapy regimen albumin paclitaxel and gemcitabine given every three weeks. The first stage enrolls 10-15 patients to assess safety and remission rates, followed by a randomized second stage comparing two cohorts receiving different combinations of these treatments. Treatment continues until disease progression or unacceptable toxicity. Throughout the study, patients undergo screening, treatment, and follow-up periods including safety and survival monitoring after treatment ends. Researchers measure objective response rate as the primary outcome up to two years, along with remission duration, disease control rate, progression-free survival, and overall survival. Vital organ functions and other health parameters are regularly assessed to monitor tolerance and treatment effects during the trial.

HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients