Phase IbII Study of HB0025 Injection With Chemotherapy for Advanced Non-Small Cell Lung Cancer and Endometrial Cancer

What this Trial Is About

Researchers are studying the safety, tolerability, and preliminary effectiveness of a drug called HB0025 combined with chemotherapy in patients with advanced solid tumors, including non-squamous and squamous non-small cell lung cancer NSCLC and advanced endometrial cancer EC. This multicenter Phase IbII clinical trial involves dose escalation to find the maximum safe dose and dose expansion to evaluate the drugs effects. The study aims to understand how well HB0025 works with chemotherapy in these patients, particularly those who have limited treatment options or have experienced disease progression after previous therapies. The trial has two main phases Phase Ib focuses on dose escalation using a 33 method to determine the maximum tolerated dose and dose-limiting toxicities of HB0025 combined with fixed doses of chemotherapy drugs, including pemetrexed, carboplatin, and paclitaxel. After initial evaluation, patients may continue multiple cycles of combined treatment followed by maintenance therapy with HB0025 alone or combined with pemetrexed, depending on their cancer type. Phase II expands the study with multiple cohorts receiving specific doses of HB0025 combined with chemotherapy to further assess safety and preliminary efficacy, with approximately 40 subjects per cohort. Participants will undergo treatment cycles every three weeks, with evaluations including tumor assessments, laboratory tests, and monitoring for side effects. Researchers will measure outcomes such as objective response rate, disease control, overall survival, progression-free survival, and treatment-related adverse events over up to 24 months. Safety and response will be closely monitored throughout the trial, with treatment continuing until disease progression, unacceptable toxicity, withdrawal, or study completion. This study provides ongoing follow-up to evaluate the drugs impact and tolerability in advanced cancer patients.

A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor