Phase IIIa Study of Oral HTL0039732 Alone and With Atezolizumab or Other Approved Cancer Therapies for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating a new drug called HTL0039732, a novel EP4 receptor antagonist, in people with advanced solid tumors. The trial aims to study HTL0039732 alone and combined with atezolizumab or other approved anti-cancer therapies. This first-in-human Phase 12a trial focuses on finding the best dose and understanding potential side effects of HTL0039732, while exploring its ability to help the immune system fight cancer by blocking a pathway that suppresses immune activity. Participants will receive HTL0039732 as oral capsules once daily in cycles of 21 days, either alone or combined with a fixed 1200 mg intravenous dose of atezolizumab given every three weeks. The trial is divided into dose escalation phases where doses of HTL0039732 are increased to find the safest and most effective dose, and a dose expansion phase where participants with specific cancer types receive the recommended dose. Additional future parts may study HTL0039732 combined with other therapies. Throughout the study, participants will be closely monitored with scans, biopsies, blood tests, and safety assessments. Researchers will track side effects, drug levels in the blood, tumor response, immune activity, and survival measures over up to 118 weeks. Safety data will be collected from consent until after treatment ends. Participants may receive up to 36 cycles of treatment if benefiting. The study will provide detailed information on dosing, safety, and anti-cancer effects of HTL0039732 in advanced solid tumors.

HTL0039732 in Participants With Advanced Solid Tumours