Actively Recruiting
IKS014 in Advanced Solid Tumors That Express HER2
Led by Iksuda Therapeutics Ltd. · Updated on 2026-05-08
165
Participants Needed
13
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
IKS014 in Advanced Solid Tumors That Express HER2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HER2 positive solid tumors defined by specific HER2 expression levels
- Prior treatment with CDK4/6 inhibitors for hormone receptor positive breast cancer (where standard)
- Platelet count of at least 75,000 /mcL
- Hemoglobin level of at least 9.0 g/dL
- Absolute neutrophil count of at least 1000/mcL
- No granulocyte colony-stimulating factor use within 2 weeks before first study drug dose
- Creatinine clearance greater than 45 mL/min
- Liver enzymes (AST/ALT) within 3 times the upper limit of normal, or 5 times if liver metastases present
- Total bilirubin within 1.5 times the upper limit of normal or less, or less than 3 times with Gilbert's Syndrome or liver metastases
- Albumin level greater than 2.5 g/dL
- Prothrombin time, INR, and PTT within defined limits
- Adequate washout before trial treatment: major surgery at least 4 weeks prior, radiation therapy at least 3 weeks prior (2 weeks if palliative)
- ECOG performance status of 0 or 1 or equivalent Karnofsky performance status
- Dose expansion cohorts include advanced/metastatic breast, gastric, gastroesophageal-junction, non-small cell lung cancers, and esophageal adenocarcinoma with specified HER2 positivity and prior treatments
You will not qualify if you...
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but unconfirmed cases
- Moderate or worse lung problems from other illnesses, or autoimmune/connective tissue diseases affecting lungs
- Current Grade 2 or higher keratitis or corneal abnormalities
- Significant eye abnormalities or findings requiring ophthalmologist assessment
- Use of contact lenses during study participation
- Untreated or unstable central nervous system metastases or brain disease
- Active second cancer or history of another cancer within 2 years, except certain treated and controlled cancers
- Clinically significant heart or liver disease
- Serious infections, infections needing IV antibiotics, or unexplained fever over 38°C within 2 weeks before first dose
- Other serious, life-threatening, or unstable medical conditions that could affect safety or compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
START Dallas - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
5
Concord Repatriation General Hospital Medical Oncology Clinical Trials Unit
Concord, New South Wales, Australia, 2139
Actively Recruiting
6
Macquarie University
Sydney, New South Wales, Australia, 2109
Actively Recruiting
7
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
8
Peninsula & South Eastern Haematology and Oncology Group (PSEHOG)
Frankston, Victoria, Australia, 3199
Actively Recruiting
9
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
10
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
11
Auckland City Hospital
Auckland, New Zealand
Actively Recruiting
12
National Cancer Centre Singapore
Singapore, Singapore
Actively Recruiting
13
Tan Tock Seng Hospital
Singapore, Singapore
Actively Recruiting
Research Team
D
David Browning
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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