Phase 1 Study of Intravenous HCB301 for Adults with Advanced Solid Tumors or Relapsed Hodgkin Lymphoma Evaluating Safety, Dosage, and Effectiveness

What this Trial Is About

Researchers are evaluating HCB301, an engineered fusion protein given by intravenous injection, as a possible treatment for adults aged 18 and older with various advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. This phase 1, open-label, multicenter study aims to understand the safety, tolerability, how the drug moves through the body, early signs of effectiveness, and the maximum dose that can be given safely. Participants must have tumors that have not responded to standard therapies or are not suitable for them. Participants receive HCB301 at increasing doses ranging from 0.3 mgkg to 15.0 mgkg through intravenous infusion. Treatment continues until unacceptable side effects occur, disease progresses as shown by scans or clinical evaluation, the participant chooses to stop, or the study ends. The dosing and escalation allow researchers to identify the best tolerated dose for future studies. During the study, participants will undergo assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response using standard criteria. The main outcomes are recording adverse events and determining the maximum tolerated dose over a 12-month period. Secondary outcomes include measuring response rates, how long responses last, disease control, and drug pharmacokinetics. Participants are followed until disease progression, withdrawal, or study completion, which may last up to 12 months.

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors