NCT05872295

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Iksuda Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Gastric Cancer
• Gastroesophageal-junction Cancer

Interventions

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

Timeline

• Start date: 2023-09-14
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-05-24
• Last updated: 2026-01-15

Locations

12 sites across 4 countries: United States, Australia, New Zealand, Singapore

Regulatory

• FDA-regulated drug study