A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors
Iksuda Therapeutics Ltd.
Summary
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.
Description
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended phase 2 dose (RP2D); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS014 at the RP2D.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested). * 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 * Absolute neutrophil count ≥ 1000/mcL * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration * Creatinine clearance \> 45/mL/min (using the Cockcroft…
Interventions
- DrugIKS014
IKS014 is a human monoclonal antibody (Ab) targeting HER2 linked to monomethyl auristatin F (MMAF) cytotoxic agent.
Locations (13)
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Dana Farber Cancer InstituteBoston, Massachusetts
- Tennessee OncologyNashville, Tennessee
- START Dallas - Fort WorthFort Worth, Texas
- Concord Repatriation General Hospital Medical Oncology Clinical Trials UnitConcord, New South Wales
- Macquarie UniversitySydney, New South Wales