NCT06763159

A Study of HS-20124 in Patients with Advanced Solid Tumors

A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20124 in Patients with Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.

Detailed description

This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20124 in patients with advanced solid tumors. The dose escalation will utilize rolling-6 design. In phase of dose expansion, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific advanced solid tumor types.

Conditions

• Solid Cancer

Interventions

Type	Name	Description
DRUG	HS-20124 (Phase Ia：Dose escalation )	Participants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
DRUG	HS-20124 (Phase Ib: Dose expansion)	Participants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Timeline

• Start date: 2024-10-30
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: China