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

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT06825624
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS-20093 — DRUG
    administered as an IV infusion
  • Bevacizumab — DRUG
    administered as an IV infusion
  • 5-FU — DRUG
    administered as an IV infusion
  • Leucovorin — DRUG
    administered as an IV infusion
  • Capecitabine — DRUG
    administered orally
  • Oxaliplatin — DRUG
    administered as an IV infusion

Study Details

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.

Key Dates

First listed
Feb 13, 2025
Start date
Oct 3, 2024
Status verified
Feb 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
560 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm1
    HS-20093 and Bevacizumab
  • Experimental: Arm 2
    HS-20093, Bevacizumab and 5-fluorouracil (5-FU), Leucovorin
  • Experimental: Arm 3
    HS-20093, Bevacizumab and 5-fluorouracil (5-FU)
  • Experimental: Arm 4
    HS-20093, Bevacizumab and capecitabine
  • Experimental: Arm 5
    HS-20093, Bevacizumab, Oxaliplatin and 5-fluorouracil (5-FU), Leucovorin

Primary Outcome Measure

Maximum tolerated dose (MTD) for combination-treatments [ Time Frame: Up to day 21 (arm 1/3/4) or 28 (arm 2/5) from the first dose ]

Central Contacts

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