RecruitingPhase 1NCT05872295

IKS014 in Advanced Solid Tumors That Express HER2

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


Sponsor

Iksuda Therapeutics Ltd.

Enrollment

165 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug conjugate called IKS014 — a targeted therapy that delivers a toxic payload directly to cancer cells expressing the HER2 protein — in people with various advanced solid tumours that have HER2 expression, including low levels. **You may be eligible if...** - You have an advanced solid tumour that has HER2 expression (even at low levels — IHC 1+ or 2+) - Your cancer has progressed after standard treatments - Your blood counts and organ function are adequate (platelets ≥75,000, haemoglobin ≥9 g/dL) - Your kidney function is adequate (creatinine clearance >45 mL/min) **You may NOT be eligible if...** - Your tumour has no HER2 expression - You have received G-CSF (white blood cell booster) injections within 2 weeks of starting the study - You have significant heart problems or uncontrolled blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIKS014

IKS014 is a human monoclonal antibody (Ab) targeting HER2 linked to monomethyl auristatin F (MMAF) cytotoxic agent.


Locations(12)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Tennessee Oncology

Nashville, Tennessee, United States

Concord Repatriation General Hospital Medical Oncology Clinical Trials Unit

Concord, New South Wales, Australia

Macquarie University

Sydney, 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

Auckland City Hospital

Auckland, New Zealand

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05872295


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