OncoMatch/Clinical Trials/NCT06504732
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
Is NCT06504732 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies IAH0968 for stomach neoplasms.
Treatment: IAH0968 — 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) according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+) (IHC 3+)
HER2 positivity (IHC 3+, or IHC 2+ and FISH +) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH)
Required: HER2 (ERBB2) amplification (IHC 2+ and FISH+) (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) low expression (IHC 2+ and FISH-, or IHC 1+) (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+) (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)
Excluded: MMR defective mismatch repair
Diagnosed defective mismatch repair (dMMR) or high microsatellite instability (MSI-H) solid tumor (except unknown MSI/MMR status)
Excluded: MSI high microsatellite instability
Diagnosed defective mismatch repair (dMMR) or high microsatellite instability (MSI-H) solid tumor (except unknown MSI/MMR status)
Disease stage
Required: Stage III, IV
locally advanced or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction) diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: adjuvant chemotherapy — adjuvant
adjuvant chemotherapy for >6 months with evidence of disease progression
Cannot have received: antitumor therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) (nitrosourea, mitomycin C)
Exception: nitrosourea or mitomycin C within 6 weeks prior to first use of study drug; oral fluorouracil analogs and small molecule targeted drugs for 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer); proprietary Chinese medicines with antitumor indications within 2 weeks prior to first use of the study drug
received antitumor therapy such as chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc. within 4 weeks prior to the first use of study drug, except for the following: Nitrosourea or mitomycin C within 6 weeks prior to first use of study drug; Oral fluorouracil analogs and small molecule targeted drugs for 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer); Within 2 weeks prior to first use of the study drug for proprietary Chinese medicines with antitumor indications.
Cannot have received: other unlisted clinical investigational drug or therapy
Received other unlisted clinical investigational drug or therapy within 4 weeks prior to first use of the study drug.
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 >1.5x ULN, creatinine clearance (Ccr) ≥50 mL/min (Cockcroft-Gault)
Liver function
total bilirubin (TBIL) ≤ 1.5x ULN (except Gilbert's syndrome); AST/ALT ≤ 3.0x ULN; for liver metastasis or HCC: AST/ALT ≤ 5.0x ULN, TBIL ≤ 3.0x ULN
Cardiac function
Mean QTcF > 470 ms, NYHA Class ≥ II heart failure or LVEF < 50% excluded
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/ALT ≤ 3.0x ULN, for liver metastasis or HCC: AST/ALT ≤ 5.0x ULN, TBIL ≤ 3.0x ULN; Renal function: serum creatinine ≤1.5x ULN; if >1.5x ULN, Ccr ≥50 mL/min (Cockcroft-Gault); Coagulation: INR ≤ 1.5x ULN, APTT ≤ 1.5x ULN, or INR and APTT ≤ 2.5x ULN for patients with liver metastasis or HCC.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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