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IKS014 in Advanced Solid Tumors That Express HER2

NCT05872295 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IKS014

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

Sponsors & Collaborators

  • Iksuda Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • James O'Leary, MD · Iksuda Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand
  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872295 on ClinicalTrials.gov