NCT06144723

Study of HS-20105 for Injection in Patients With Advanced Solid Tumors.

Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic and the Therapeutic Potential of HS-20105 for Injection in Patients With Advanced Solid Tumors.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20105 is a novel antibody-drug conjugate (ADC) targeting Trop-2. This first-in-human trial is aimed to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics (PK), safety and preliminary anti-tumor activity of HS-20105 in patients with advanced solid tumors.

Detailed description

This is a multicenter, open-label Phase I clinical study evaluating the safety, tolerability, PK, and efficacy of HS-20105 in patients with advanced solid tumors. The study includes Phase Ia (dose escalation) and Phase Ib (dose extension). Phase Ia will conduct a dose escalation using the "Rolling 6" design in advanced solid tumor patients who have failed or are unable to tolerate standard treatment, to evaluate the safety, tolerability, PK characteristics, and efficacy of HS-20105. The subsequent Phase Ib study will be conducted in certain population to evaluate the preliminary efficacy of HS-20105 at different doses and in different populations.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-20105	Administered intravenously every 21 days.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2023-11-22
• Last updated: 2023-11-22