IKS014 for HER2-Positive Advanced Solid Tumors
This study is testing a new treatment called IKS014 for advanced solid tumors, including breast cancer, gastric cancer, and gastroesophageal-junction cancer, that have a protein called HER2. IKS014 is an antibody-drug conjugate (ADC), which means it's a targeted therapy that delivers a powerful drug directly to cancer cells with HER2. The study aims to find the safest and most effective dose of IKS014 and see how well it shrinks tumors. You might be able to join if you are 18 or older, have HER2-positive solid tumors (meaning your cancer cells have a certain level of the HER2 protein), and meet other health requirements like specific blood counts. The study plans to enroll 165 participants.
- Study design
- This study has two parts: first, a dose-escalation part to find the best dose, and then a dose-expansion part to further evaluate that dose. It is an interventional study, meaning participants will receive the study drug.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure outcomes for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05872295
IKS014 in Advanced Solid Tumors That Express HER2
Recruiting
PHASE1Ages 18+InterventionalTreatmentIksuda Therapeutics Ltd.
~165 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:IKS014
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose (Part 1)
Measured over Up to 24 months
+1 more outcome measured
Conditions
Where it's being run
13 sites across 9 statesNew South Wales3
Victoria2
Singapore2
California1
Massachusetts1
Tennessee1
Texas1
Western Australia1
Study leadership
- James O'Leary, MD · STUDY_DIRECTOR · Iksuda Therapeutics
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested).
Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
Platelets ≥ 75,000 /mcL
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1000/mcL
No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration
Creatinine clearance \> 45/mL/min (using the Cockcroft-Gault equation)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present
Total bilirubin ≤ 1.5 x ULN if no liver metastases or \< 3 x ULN with Gilbert's Syndrome or liver metastases at baseline
Albumin \> 2.5 g/dL
Prothrombin time or international normalized ratio (INR) and either partial thromboplastin time (PTT) or activated (a) PTT ≤ 1.5 x ULN, ≤ 3 x institutional ULN if anticoagulated.
Must have adequate treatment washout period before trial treatment, defined as: Major surgery (≥ 4 weeks) and radiation therapy (≥ 3 weeks; in case of palliative radiation ≥ 2 weeks)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS)
Part 2 Dose Expansion Cohorts May Include:
Exclusion
History of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.
Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.
Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.
Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity.
Participant must not use contact lenses while participating in this study.
Central nervous system metastatic disease unless treated with definitive local therapy (surgical resection, stereotactic radiotherapy, or whole brain radiotherapy) and participant is clinically, radiologically and neurologically stable for at least 4 weeks prior to the first dose of study drug not on steroid therapy or are on a stable or decreasing dose of steroids for at least 7 days prior to first dose of study drug. Prophylactic anticonvulsant medications are allowed.
Active second malignancy or history of another malignancy within the last 2 years with the exception of:
Treated, non-melanoma skin cancers
Treated carcinoma in situ (CIS) (e.g., breast, cervix)
Controlled, superficial carcinoma of the urinary bladder
T1a or b carcinoma of the prostate treated according to local standard of care, with prostate specific antigen (PSA) within normal limits (WNL) for the institution
Papillary thyroid carcinoma Stage I treated surgically for cure
Clinically significant cardiovascular disease or condition
Clinically significant liver disease
Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \> 38ºC within 2 weeks prior to first trial drug administration.
Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy), including significant organ system dysfunction, or clinically significant laboratory abnormality(ies), which, in the opinion of the Investigator, would either compromise the participant's safety or interfere with obtaining informed consent, compliance with trial procedures, or evaluation of the safety of the trial drug.
What this trial measures
- Recommended Phase 2 Dose (Part 1)Up to 24 months
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
- Objective Response Rate (Part 2)Up to 24 months
Anti-tumor activity will be assessed by RECIST 1.1