Open-Label Phase 1 Trial Evaluating Safety and Activity of HH160 Alone or With Other Cancer Treatments in Adults With Advanced or Metastatic Solid Tumors

What This Trial Is About

Researchers are evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in adults with advanced or metastatic solid tumors. This phase 1 trial aims to find the recommended dose for future studies. It includes various tumor types such as lung, liver, colorectal, breast, and other cancers. Participants will receive HH160 through intravenous infusion on either a 14-day or 21-day cycle. The study has multiple parts dose escalation to find tolerable levels, safety expansion at those doses, and dose expansion where HH160 is given alone or with chemotherapy. The trial is expected to last about four years, with treatment and follow-up each lasting about 6 to 12 months. During the study, participants will have regular safety checks, laboratory tests, and imaging to measure tumor response according to RECIST criteria. Researchers will monitor side effects, drug levels in the body, immune response, and how well the tumors respond. The main outcomes include treatment-emergent adverse events, maximum tolerated dose, recommended phase 2 dose, and overall tumor response over up to two years.

A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors