OncoMatch/Clinical Trials/NCT06504732
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
Is NCT06504732 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2/3 trial studies multiple treatments including IAH0968 and Trastuzumab for stomach neoplasms.
Treatment: IAH0968 · Trastuzumab — The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects with HER2-expressing advanced/metastatic colorectal or gastric cancers (including adenocarcinomas of the gastro-esophageal junction) or HER2-hypo-expressing advanced/metastatic solid tumors. The efficacy of IAH0968 in combination with the CAPEOX regimen versus trastuzumab in combination with the CAPEOX regimen in subjects with HER2-positive advanced/metastatic gastric cancer, including gastro-esophageal junction adenocarcinoma, was then assessed by progression-free survival (PFS) and OS according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Gastric Cancer
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and FISH+)
HER2 positivity (IHC 3+, or IHC 2+ and FISH +) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH)
Required: HER2 (ERBB2) underexpression (IHC 2+ and FISH-, or IHC 1+)
HER2 underexpressed (IHC 2+ and FISH-, or IHC 1+) as evidenced by immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH)
Required: HER2 (ERBB2) low expression (IHC 2+ and FISH-, or IHC 1+)
HER2 low expression (IHC 2+ and FISH-, or IHC 1+) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH)
Required: KRAS wild-type
patients with wild-type KRAS, NRAS, and BRAF genes (mCRC only)
Required: NRAS wild-type
patients with wild-type KRAS, NRAS, and BRAF genes (mCRC only)
Required: BRAF wild-type
patients with wild-type KRAS, NRAS, and BRAF genes (mCRC only)
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and FISH+)
HER2 positivity shall be confirmed via immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH): defined as IHC 3+, or IHC 2+ with positive FISH result
Required: PD-L1 (CD274) expression (PD-L1 CPS score <1)
PD-L1 expression testing on primary or metastatic tumor tissue samples confirms a PD-L1 CPS score <1
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L, PLT ≥ 90 × 10^9/L, HGB ≥ 90 g/L; no transfusion or hematopoietic stimulating factor therapy within 14 days
Kidney function
serum creatinine ≤1.5x ULN; if creatinine >1.5x ULN, creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
total bilirubin (TBIL) ≤ 1.5x ULN (except Gilbert's syndrome); AST and ALT ≤ 3.0x ULN; for liver metastasis or hepatocellular carcinoma: AST and ALT ≤ 5.0x ULN, TBIL ≤ 3.0x ULN
Cardiac function
NYHA Cardiac Function Class < Grade II heart failure; LVEF ≥ 50%; no severe cardiac rhythm/conduction abnormalities; QTcF ≤ 470 ms; no acute coronary syndrome, CHF, aortic coarctation, stroke, or grade 3+ cardiovascular event within 6 months
Adequate organ function: Hematologic system (no transfusion or hematopoietic stimulating factor therapy within 14 days): ANC ≥ 1.5 × 10^9/L, PLT ≥ 90 × 10^9/L, HGB ≥ 90 g/L; Liver function: TBIL ≤ 1.5x ULN (except Gilbert's syndrome); AST and ALT ≤ 3.0x ULN; for liver metastasis or hepatocellular carcinoma: AST and ALT ≤ 5.0x ULN, TBIL ≤ 3.0x ULN; Renal function: serum creatinine ≤1.5x ULN; if creatinine >1.5x ULN, creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); Cardiac: NYHA Cardiac Function Class < Grade II heart failure; LVEF ≥ 50%; no severe cardiac rhythm/conduction abnormalities; QTcF ≤ 470 ms; no acute coronary syndrome, CHF, aortic coarctation, stroke, or grade 3+ cardiovascular event within 6 months
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06504732 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 underexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 low expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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