IKS014 in Advanced Solid Tumors That Express HER2

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

Trial Details

NCT ID
NCT05872295
Phase
PHASE1
Sponsor
Iksuda Therapeutics Ltd.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • IKS014
Locations (sample)
  • Newport Beach, California, United States|33.61891,-117.92895
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Fort Worth, Texas, United States|32.72541,-97.32085
  • Concord, New South Wales, Australia|-33.84722,151.10381

Key Eligibility Criteria

  • HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untest…
  • Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
  • Platelets ≥ 75,000 /mcL
  • Hemoglobin ≥ 9.0 g/dL

For full eligibility, visit ClinicalTrials.gov.

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