Actively Recruiting
Study of IAH0968 With or Without CAPEOX Chemotherapy in HER2-Positive Advanced or Metastatic Gastric Cancer and Solid Tumors A Phase II/III Clinical Trial Assessing Safety and Efficacy
Led by SUNHO（China）BioPharmaceutical CO., Ltd. · Updated on 2025-01-20
90
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and optimal dose of IAH0968 combined with or without the CAPEOX chemotherapy regimen in people with HER2-expressing advanced or metastatic colorectal or gastric cancers, including adenocarcinomas of the gastro-esophageal junction, as well as HER2-low expressing advanced/metastatic solid tumors. This Phase II/III clinical trial aims to compare the effectiveness of IAH0968 plus CAPEOX versus trastuzumab plus CAPEOX in patients with HER2-positive advanced or metastatic gastric cancer, assessing progression-free survival using RECIST 1.1 criteria. Participants receive IAH0968 with or without the CAPEOX regimen in treatment cycles lasting 3 weeks each, with IAH0968 given for up to 35 cycles. The study has two phases: an open-label, nonrandomized Phase II with three cohorts, and a randomized, parallel-controlled, multicenter Phase III study. Tumor assessments occur every 6 weeks starting from the first study drug infusion until disease progression or other criteria for stopping treatment are met. During the study, researchers monitor adverse events through clinical observations, vital signs, and lab tests, while collecting pharmacokinetic and immunogenicity samples. After stopping treatment, participants undergo additional laboratory tests and are followed by phone every 12 weeks to track survival until loss to follow-up or death. The study measures the number of participants experiencing adverse events, treatment discontinuations due to adverse events, and progression-free survival over approximately 48 months.
CONDITIONS
Official Title
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any gender
- For Phase II Cohort 1 and Phase III: diagnosed locally advanced or metastatic gastric cancer including gastro-esophageal junction adenocarcinoma, unsuitable for surgery or localized treatment, not previously treated systemically (except adjuvant >6 months), with disease progression and HER2 positive status
- For Phase II Cohort 2: advanced malignant solid tumors confirmed by biopsy, failed or lacking standard treatments, HER2 underexpressed as shown by IHC or FISH
- For Phase II Cohort 3: locally advanced or metastatic gastric or colorectal cancer, unsuitable for surgery, no prior systemic therapy (except adjuvant >6 months with progression), wild-type KRAS, NRAS, and BRAF genes (colorectal only), HER2 low expression
- At least one measurable tumor lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function including blood counts, liver, kidney, and coagulation parameters within defined limits
- Patients of childbearing potential must agree to reliable contraception during and for 6 months after treatment, and female patients must have a negative pregnancy test within 7 days before first dose
- Signed informed consent prior to participation
You will not qualify if you...
- For Phase II Cohort 2: received antitumor therapy within 4 weeks before first study drug dose except allowed exceptions
- Use of other investigational drugs or therapies within 4 weeks before first dose
- Unresolved adverse effects from prior cancer therapy above grade 1 except certain stable conditions
- Known severe allergy to antibody drugs or study medications
- Diagnosed defective mismatch repair or high microsatellite instability tumors (unless unknown status)
- Major surgery, trauma, or planned surgery during the trial within 4 weeks before first dose
- Use of systemic glucocorticosteroids (>10 mg prednisone daily) within 14 days before first dose, except certain forms and short-term use
- Other immunosuppressive therapy or immunomodulatory drugs within defined periods prior to first dose
- Live vaccine use within 4 weeks before first dose
- Previous allogeneic stem cell or organ transplantation
- Symptomatic brain or meningeal metastases
- Active infection requiring intravenous antibiotics
- History of immunodeficiency including HIV positive
- Active hepatitis B or C infection
- Severe uncontrolled lung disease
- Severe cardiovascular disease including arrhythmias, recent major cardiac events, heart failure, or uncontrolled hypertension
- Active or unstable autoimmune disease except certain stable conditions
- Other malignancies within 5 years except those with expected cure
- Clinically uncontrollable third interstitial fluid
- Known alcohol or drug dependence
- Mental disorder or poor compliance
- Pregnant or breastfeeding females
- Other serious systemic diseases or conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 637000
Actively Recruiting
2
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
Research Team
Z
Zhenning Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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