Stomach NeoplasmsPhase 2/3NCT06504732

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer

A Phase 2/3 study testing IAH0968 and Trastuzumab Injection in people with Stomach Neoplasms and Solid Tumor, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Stomach Neoplasms, Solid Tumor
What is being tested?: IAH0968 and Trastuzumab Injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 574 participants
Where: 2 sitesChina
Study dates: 15 Aug 2024to Jul 2029
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1) Age 18~75 years old (including critical mass), gender is not limited. 2) Phase II cohort 1 only: patients with locally advanced or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction) diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment, and who have not received systemic antitumor therapy (including systemic chemotherapy, molecularly-targeted drug therapy, biologic therapy, and other investigational therapeutic agents) for GC (except for adjuvant chemotherapy for >6 months), and who have demonstrated disease progression; and patients who have been diagnosed by immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH). and demonstrated disease progression excepted); HER2 positivity (IHC 3+, or IHC 2+ and FISH +) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH).
3) Phase II Cohort 2 only: Have histologically or cytologically confirmed advanced malignant solid tumors that have failed standard treatment, or for which no standard treatment options are available, or for which standard treatment is not applicable at this stage; and are HER2 underexpressed (IHC 2+ and FISH-, or IHC 1+) as evidenced by immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH).
4) Phase II Cohort 3 only: with locally advanced or metastatic gastric cancer (including gastro-oesophageal junction adenocarcinoma) or colorectal cancer diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment, with no prior systemic (including systemic chemotherapy, molecularly-targeted drug therapy, biologic therapy, and other investigational therapeutic agents) antitumor therapy (having received adjuvant chemotherapy for >6 months with evidence of disease progression), patients with wild-type KRAS, NRAS, and BRAF genes (mCRC only); and HER2 low expression (IHC 2+ and FISH-, or IHC 1+) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH).
5) At least 1 measurable lesion according to RECIST 1.1 criteria (tumor lesions located in the area of prior radiotherapy or other localized regional treatment sites are generally not considered measurable lesions unless the lesion shows definite progression or persists after three months of radiotherapy).
6) Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1. 7) Have an expected survival of ≥ 3 months. 8) Adequate organ function:
① Hematologic system (no transfusion or hematopoietic stimulating factor therapy within 14 days): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 90 × 109/L, hemoglobin (HGB) ≥ 90 g/L; Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), except Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times the ULN, liver metastasis or hepatocellular carcinoma patients need to AST and ALT ≤ 5.0 times the ULN and total bilirubin ≤ 3.0 times the ULN; Renal function: serum creatinine (Cr) ≤1.5 times ULN; if creatinine >1.5 times ULN, creatinine clearance (Ccr) ≥50 mL/min (calculated according to Cockcroft-Gault formula);

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④ Coagulation function: International Normalized Ratio (INR) ≤ 1.5 times ULN for prothrombinogen, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN, or INR and APTT ≤ 2.5 times ULN for patients with liver metastasis or hepatocellular carcinoma.
9) Eligible patients (male and female) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 6 months after the last dose; female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.
10) Subjects must give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
11)Phase III only: Patients with histologically confirmed locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma), who have received no prior systemic anti-tumor therapy for gastric carcinoma (GC), including systemic chemotherapy, molecular targeted therapy, biotherapy and other investigational medicinal products. One cycle of 5-FU-based chemotherapy is permitted; patients who received neoadjuvant/adjuvant chemotherapy completed ≥6 months previously with documented disease progression are also eligible. 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. PD-L1 expression testing on primary or metastatic tumor tissue samples confirms a PD-L1 CPS score <1.

Who cannot join

1) Phase II Cohort 2 only: 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.
2) Received other unlisted clinical investigational drug or therapy within 4 weeks prior to first use of the study drug.
3) Adverse effects of prior antineoplastic therapy have not returned to NCI CTCAE 5.0 grade rating of ≤ grade 1 or relevant provisions of the enrollment criteria (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy).

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4) Known hypersensitivity to any antibody-based drug (NCI CTCAE 5.0 grade rating ≥ 3) or hypersensitivity to the study drug and the active ingredient or inactive excipients of the CAPEOX regimen.
5) Diagnosed defective mismatch repair (dMMR) or high microsatellite instability (MSI-H) solid tumor (except unknown MSI/MMR status).
6) Major surgical procedure (excluding puncture biopsy), major trauma within 4 weeks prior to first use of study drug, or need for elective surgery during the trial.
7) Received systemic glucocorticosteroids (prednisone > 10 mg/day or equivalent) within 14 days prior to the first dose of study drug, except for the following: treatment with topical, ocular, intra-articular, intranasal, and inhaled glucocorticosteroids; and short-term prophylactic glucocorticosteroids (e.g., for prevention of allergy to contrast media).
8) Other immunosuppressive therapy within 28 days or 5 half-lives (whichever is longer) prior to first use of study drug.
9) Use of immunomodulatory drugs within 14 days prior to first use of study drug.
10) Use of any live vaccine within 4 weeks prior to the first dose of study drug.
11) Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
12) Parenchymal brain metastases or meningeal metastases with clinical symptoms.
13) Have an active infection that currently requires intravenous anti-infective therapy.
14) Have a history of immunodeficiency, including a positive antibody test for human immunodeficiency virus (HIV).
15) Have active hepatitis B (HBsAg positive and HBV-DNA positive or greater than the upper limit of normal) and active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive or greater than the upper limit of normal).
16) Have severe and uncontrollable lung disease (severe infectious pneumonia, interstitial lung disease, etc.).
17) Have a history of severe cardiovascular disease, including but not limited to:
Having severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block;
Mean QT interval (QTcF) corrected by the Fridericia method > 470 ms;
Acute coronary syndrome, congestive heart failure, aortic coarctation, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to the first dose;
④ Presence of New York Heart Association (NYHA) Cardiac Function Class ≥ Grade II heart failure or left ventricular ejection fraction (LVEF) < 50%, or other structural heart disease judged by the investigator to be of high risk;
⑤ Clinically uncontrolled hypertension. 18) Active, or previous autoimmune disease with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid disease, type I diabetes mellitus, vitiligo, cured atopic dermatitis in children, and psoriasis that does not require systemic therapy (within the past 2 years).
19) Presence of other malignancies within 5 years prior to the start of study dosing, except: malignancies for which cure can be expected with treatment (including, but not limited to, adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery).
20) Presence of clinically uncontrollable third interstitial fluid that, in the judgment of the Investigator, makes enrollment inappropriate.
21) Known alcohol or drug dependence. 22) Have a mental disorder or poor compliance. 23) Pregnant or lactating females. 24) In the opinion of the investigator, the subject has a history of other serious systemic disease or is otherwise unsuitable for enrollment in this clinical study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenning Wang, PhD contact

13998891377

JOSIEON826@sina.cn

China2 sites, 2 recruiting

Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
yanqiao Zhang, Dr., 13845120210, yanqiaozhang@126.com
Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 637000
Qu Xiujuan Dr.QU, 024-83282256, qu_xiujuan@hotmail.com
Qu Xiujuan Dr.QU, PhD
Recruiting

Other trials in China

About this study

Official title: A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumors and Gastric Cancer

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.

Read the detailed description

This clinical study is a randomized, multicenter Phase II/III clinical study to investigate the efficacy of IAH0968 in combination or not in combination with the CAPEOX regimen in the treatment of subjects with HER2-expressing advanced/metastatic solid tumors and gastric cancer. The study is divided into two study phases: a Phase II clinical study and a Phase III clinical study.

Adverse events and adverse reactions were assessed in the study through clinical observation, vital signs monitoring, laboratory tests, etc., while PK, ADA and other relevant samples were collected; and using RECIST 1.1 as the standard for tumor assessment, subjects were assessed for tumors every 6 weeks starting from the first infusion of the study drug until the occurrence of disease progression, the initiation of new antitumor therapy, and the judgement of the investigator that it was not suitable for continued participation (e.g., development of intolerable adverse reactions), loss to visit, voluntary withdrawal, death, or study termination/suspension.

Upon withdrawal or termination of treatment (+7 days), subjects should be visited for termination of treatment (except in the case of death and loss to follow-up), as far as possible, prior to the initiation of new antitumor therapy, with relevant laboratory investigations and ADA samples, and thereafter followed up by telephone every 12 weeks (±7 days) for survival (OS) until loss to follow-up or death.

The phase II study was an open-label, nonrandomized clinical study, which was planned to be divided into 3 cohorts.The phase III study used a randomized, parallel-controlled, multicenter study design.

Conditions: Stomach Neoplasms, Solid Tumor
Being tested: IAH0968, Trastuzumab Injection
Keywords: gastric cancer, HER2-positive
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IAH0968Drug
Experimental：IAH0968 15 mg/kg on Day 1 of each 3-week cycle as an IV infusion. Drug: Oxaliplatin 130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen.
Drug: Capecitabine 1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
Trastuzumab InjectionDrug
Active Comparator: Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Drug: Oxaliplatin 130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen.
Drug: Capecitabine 1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.

Study groups in NCT06504732
Study group	Role	What they receive
Cohort A	Experimental	IAH0968+CAPEOX Receives: Drug: IAH0968
Cohort B	Active comparator	Trastuzumab Injection +CAPEOX Receives: Drug: Trastuzumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Measured: Up to approximately 48 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.
Measured: Up to approximately 48 months
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 2024Jul 2029

First posted17 Jul 2024
Study start15 Aug 2024
Primary completionJul 2028 (estimated)
Study completionJul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
More trials run by SUNHO（China）BioPharmaceutical CO., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The Phase II trial is designed as an open-label, non-randomized clinical study planned to consist of three cohorts. The Phase III trial adopts a randomized, double-blind, parallel-group, multicenter study design. Under the 15 mg/kg dosage cohort, treatment-naive subjects with HER2-positive unresectable locally advanced or metastatic gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) who have not received prior systematic anti-tumor therapy will be enrolled. This trial aims to evaluate the efficacy of IAH0968 in combination with the CAPEOX regimen for subjects suffering from HER2-positive advanced/metastatic gastric cancer. Eligible subjects will be randomized at a 1:1 allocation ratio into two arms: Arm A receiving IAH0968 plus CAPEOX regimen, and Arm B receiving trastuzumab plus CAPEOX regimen.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 574 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06504732
Sponsor's protocol ID: IAH0968-203
Status last verified: Apr 2026
First submitted: 10 Jul 2024
Last updated: 5 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumors and Gastric Cancer
ClinicalTrials.gov ID: NCT06504732
Acronym / sponsor ID: IAH0968-203
Conditions: Stomach Neoplasms, Solid Tumor
Keywords: gastric cancer, HER2-positive
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 574 participants (estimated)
Lead sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Aug 2024 (actual)
Primary completion: Jul 2028 (estimated)
Study completion: Jul 2029 (estimated)
First posted: 17 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: The Phase II trial is designed as an open-label, non-randomized clinical study planned to consist of three cohorts. The Phase III trial adopts a randomized, double-blind, parallel-group, multicenter study design. Under the 15 mg/kg dosage cohort, treatment-naive subjects with HER2-positive unresectable locally advanced or metastatic gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) who have not received prior systematic anti-tumor therapy will be enrolled. This trial aims to evaluate the efficacy of IAH0968 in combination with the CAPEOX regimen for subjects suffering from HER2-positive advanced/metastatic gastric cancer. Eligible subjects will be randomized at a 1:1 allocation ratio into two arms: Arm A receiving IAH0968 plus CAPEOX regimen, and Arm B receiving trastuzumab plus CAPEOX regimen.

Arm	Type	Receives
Cohort A	Experimental	Drug: IAH0968IAH0968+CAPEOX
Cohort B	Active comparator	Drug: Trastuzumab InjectionTrastuzumab Injection +CAPEOX

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1) Age 18~75 years old (including critical mass), gender is not limited. 2) Phase II cohort 1 only: patients with locally advanced or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction) diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment, and who have not received systemic antitumor therapy (including systemic chemotherapy, molecularly-targeted drug therapy, biologic therapy, and other investigational therapeutic agents) for GC (except for adjuvant chemotherapy for >6 months), and who have demonstrated disease progression; and patients who have been diagnosed by immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH). and demonstrated disease progression excepted); HER2 positivity (IHC 3+, or IHC 2+ and FISH +) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH).
3) Phase II Cohort 2 only: Have histologically or cytologically confirmed advanced malignant solid tumors that have failed standard treatment, or for which no standard treatment options are available, or for which standard treatment is not applicable at this stage; and are HER2 underexpressed (IHC 2+ and FISH-, or IHC 1+) as evidenced by immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH).
4) Phase II Cohort 3 only: with locally advanced or metastatic gastric cancer (including gastro-oesophageal junction adenocarcinoma) or colorectal cancer diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment, with no prior systemic (including systemic chemotherapy, molecularly-targeted drug therapy, biologic therapy, and other investigational therapeutic agents) antitumor therapy (having received adjuvant chemotherapy for >6 months with evidence of disease progression), patients with wild-type KRAS, NRAS, and BRAF genes (mCRC only); and HER2 low expression (IHC 2+ and FISH-, or IHC 1+) demonstrated by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH).
5) At least 1 measurable lesion according to RECIST 1.1 criteria (tumor lesions located in the area of prior radiotherapy or other localized regional treatment sites are generally not considered measurable lesions unless the lesion shows definite progression or persists after three months of radiotherapy).
6) Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1. 7) Have an expected survival of ≥ 3 months. 8) Adequate organ function:

Key exclusion criteria (28 listed)

1) Phase II Cohort 2 only: 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:
2) Received other unlisted clinical investigational drug or therapy within 4 weeks prior to first use of the study drug.
3) Adverse effects of prior antineoplastic therapy have not returned to NCI CTCAE 5.0 grade rating of ≤ grade 1 or relevant provisions of the enrollment criteria (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy).
4) Known hypersensitivity to any antibody-based drug (NCI CTCAE 5.0 grade rating ≥ 3) or hypersensitivity to the study drug and the active ingredient or inactive excipients of the CAPEOX regimen.
5) Diagnosed defective mismatch repair (dMMR) or high microsatellite instability (MSI-H) solid tumor (except unknown MSI/MMR status).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IAH0968Experimental：IAH0968 15 mg/kg on Day 1 of each 3-week cycle as an IV infusion. Drug: Oxaliplatin 130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen. Drug: Capecitabine 1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.	Drug	Cohort A
Trastuzumab InjectionActive Comparator: Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle. Drug: Oxaliplatin 130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen. Drug: Capecitabine 1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.	Drug	Cohort B

Primary outcome

Number of Participants Who Experienced At Least One Adverse Event (AE)
Time frame: Up to approximately 48 months
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Time frame: Up to approximately 48 months
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 48 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Zhenning Wang, PhD contact

13998891377

JOSIEON826@sina.cn

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing IAH0968 and Trastuzumab Injection in people with Stomach Neoplasms and Solid Tumor, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhenning Wang, PhD (13998891377, JOSIEON826@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced At Least One Adverse Event (AE) (time frame: Up to approximately 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06504732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.