NCT06936735

Phase I Study of HS-20108 in Participants With Advanced Solid Tumors

A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20108 in Participants With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 502 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I clinical study of HS-20108. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors.

Detailed description

This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors. The study consists of Phase Ia (dose escalation) and Phase Ib (dose expansion). In Phase Ia, dose escalation will conduct to identify the maximum tolerated dose (MTD) in patients with advanced solid tumors. In Phase Ib, potential indications (such as small cell lung cancer or neuroendocrine carcinoma) will be selected for the early proof-of-concept study of HS-20108 at different doses based on the study data from Phase Ia, the translational medicine research data and R\&D progress in the field.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-20108 Monotherapy	Intravenous (IV) Infusion

Timeline

• Start date: 2025-04-17
• Primary completion: 2027-10-28
• Completion: 2027-11-27
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: China