NCT06825624

ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer

ARTEMIS-102: a Phase Ib Study of HS-20093 Combination Therapy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents in patients with advanced metastatic colorectal cancer.

Detailed description

This is a phase 1b, open-label, multi-center, dose-escalation and expansion, phase 1b study in Chinses subjects with advanced metastatic colorectal cancer. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents. A total of 5 combination-treatments will be carried out in 5 cohorts. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received treatment for advanced metastatic colorectal cancer. All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Conditions

• Metastatic Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	HS-20093	administered as an IV infusion
DRUG	Bevacizumab	administered as an IV infusion
DRUG	5-FU	administered as an IV infusion
DRUG	Leucovorin	administered as an IV infusion
DRUG	Capecitabine	administered orally
DRUG	Oxaliplatin	administered as an IV infusion

Timeline

• Start date: 2024-10-03
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2025-02-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: China