OncoMatch/Clinical Trials/NCT05872295
IKS014 in Advanced Solid Tumors That Express HER2
Is NCT05872295 recruiting? Yes, currently enrolling (May 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
Cancer type
Breast Carcinoma
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC3+) (IHC3+)
HER2 positive solid tumors with expression defined as IHC3+
Required: HER2 (ERBB2) overexpression (IHC2+/ISH+) (IHC2+/ISH+)
HER2 positive solid tumors with expression defined as IHC2+/ISH+
Required: HER2 (ERBB2) low expression (IHC2+/ISH-) (IHC2+/ISH-)
low HER2 expression defined as IHC2+ (ISH-)
Required: HER2 (ERBB2) low expression (IHC1+) (IHC1+ (ISH-/+ or untested))
low HER2 expression defined as IHC1+ (ISH- /+ or untested)
Required: HER2 (ERBB2) amplification
evidence of HER2 amplification by ISH
Required: HER2 (ERBB2) activating mutation
a known activating HER2 mutation
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 this is standard therapy
Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
Must have received: HER2-targeted therapy — HER2-positive advanced or metastatic breast cancer
previously treated with at least two HER2 directed treatments
Must have received: chemotherapy — HER2-low advanced or metastatic breast cancer
previously treated with at least 1 prior line of therapy which may include chemotherapy and/or a HER2 directed ADC
Must have received: HER2-targeted therapy — HER2-low advanced or metastatic breast cancer
previously treated with at least 1 prior line of therapy which may include chemotherapy and/or a HER2 directed ADC
Must have received: chemotherapy — HER2-positive advanced or metastatic gastric or GEJ cancer
previously treated with at least 1 prior line of therapy, which may include chemotherapy and/or a HER2 directed ADC
Must have received: HER2-targeted therapy — HER2-positive advanced or metastatic gastric or GEJ cancer
previously treated with at least 1 prior line of therapy, which may include chemotherapy and/or a HER2 directed ADC
Must have received: chemotherapy — HER2-low advanced or metastatic gastric or GEJ cancer
previously treated with at least one prior line of therapy
Must have received: standard of care therapy — advanced or metastatic solid tumor
has been treated with standard of care therapy relevant to the disease
Lab requirements
Blood counts
Platelets ≥ 75,000 /mcL; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1000/mcL
Kidney function
Creatinine clearance > 45/mL/min (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
Platelets ≥ 75,000 /mcL; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1000/mcL; Creatinine clearance > 45/mL/min (using the Cockcroft-Gault equation); 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
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Dana Farber Cancer Institute · Boston, Massachusetts
- Tennessee Oncology · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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