Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

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

IKS014

David Browning

Tam Bui, MD

Adnan Nagrial, MD

Vinod Ganju, MD

Malaka Ameratunga, MD

Peter Lau, MD

James O'Leary, MD

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.

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.

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

Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics

Anti-tumor activity will be assessed by RECIST 1.1

Pharmacokinetic parameters will be determined from observed concentrations of IKS014

Occurrence of ADA measured in serum at selected timepoints during the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IKS014 in Advanced Solid Tumors That Express HER2	NCT05872295	Breast Cancer Gastric Cancer Gastroesophagea...	IKS014	18 Years -	Iksuda Therapeutics Ltd.
IKS014 in Advanced Solid Tumors That Express HER2	NCT05872295	Breast Cancer Gastric Cancer Gastroesophagea...	IKS014	18 Years -	Iksuda Therapeutics Ltd.

Spots Global Cancer Trial Database for iks014

Every month we try and update this database with for iks014 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iks014

Every month we try and update this database with for iks014 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iks014 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.