Phase II Study of MHB036C and MHB039A Combination Therapy for Adults With Advanced Breast Cancer or Other Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the combination of two drugs, MHB036C and MHB039A, in patients with advanced breast cancer or other advanced malignant solid tumors. This open-label Phase II trial aims to assess the safety, tolerability, how the body processes the drugs, and the early effects of this combination therapy. The study includes patients with locally advanced or metastatic solid tumors who have measurable lesions and meet specific health criteria. The trial has two main parts a safety run-in phase and an indication expansion phase. The safety run-in phase involves dose escalation and may include an optional pharmacokinetic expansion to better understand how the drugs behave in the body at safe dose levels. After evaluating safety and early results, the indication expansion phase will further assess the combinations safety and effectiveness in different patient groups. Participants receive both MHB036C and MHB039A through intravenous infusions every three weeks. Participants will be closely monitored throughout the study, which can last up to about five years. Researchers will evaluate tumor response, disease control, progression-free survival, overall survival, and any side effects using established criteria and assessments. Blood samples will be taken to study drug levels over time. The study will track participants until disease progression, death, loss to follow-up, or withdrawal, ensuring thorough safety and efficacy monitoring during this period.

A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors