OncoMatch/Clinical Trials/NCT05872295
IKS014 in Advanced Solid Tumors That Express HER2
Is NCT05872295 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies IKS014 for breast cancer.
Treatment: IKS014 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) activating mutation
Required: HER2 (ERBB2) amplification
Required: HER2 (ERBB2) expression (ihc3+, ihc2+/ish+, ihc2+ (ish-), ihc1+ (ish-/+ or untested))
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cdk4/6 inhibitor — hr positive breast cancer (in countries where standard)
Must have received: her2-targeted therapy — advanced or metastatic breast cancer
Must have received: systemic therapy — advanced or metastatic breast cancer with low her2 expression
Must have received: systemic therapy — advanced or metastatic gastric or gej cancer
Must have received: systemic therapy — advanced or metastatic solid tumor
Must have received: systemic therapy — metastatic nsclc
Must have received: systemic therapy — advanced or metastatic adenocarcinoma of the esophagus
Lab requirements
Blood counts
platelets ≥ 75,000 /mcl; hemoglobin ≥ 9.0 g/dl; absolute neutrophil count ≥ 1000/mcl; no administration of g-csf within 2 weeks prior to first study drug administration
Kidney function
creatinine clearance > 45/ml/min (using cockcroft-gault equation)
Liver function
ast/alt ≤ 3 x 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Tennessee Oncology · Nashville, Tennessee
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Dana Farber Cancer Institute · Boston, Massachusetts
- START Dallas - Fort Worth · Fort Worth, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05872295 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cdk4/6 inhibitor and her2-targeted therapy.
Does this trial require ERBB2?
Yes, ERBB2 activating mutation is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify