The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: IKS014 in Advanced Solid Tumors That Express HER2
Official Title: 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
Study ID: NCT05872295
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Concord Repatriation General Hospital Medical Oncology Clinical Trials Unit, Concord, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Peninsula & South Eastern Haematology and Oncology Group (PSEHOG), Frankston, Victoria, Australia
Alfred Health, Melbourne, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Name: James O'Leary, MD
Affiliation: Iksuda Therapeutics
Role: STUDY_DIRECTOR