Combination treatment for advanced gastroesophageal adenocarcinoma with moderate HER2 expression

A Multicenter, Open Label，Single Arm，Phase Ib/II Study to Evaluate the Effect and Safety of RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

This study is testing a new combination treatment for people with advanced stomach cancer that has moderate HER2 expression to see if it helps them feel better as a first treatment option.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT05403242 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment using RC48-ADC and S-1 as a first-line therapy for patients with advanced gastroesophageal adenocarcinoma that shows moderate expression of HER2. It is a single-arm, open-label trial conducted across multiple centers, focusing on patients who have not received prior systemic therapy or have experienced disease progression after previous treatments. The study aims to provide insights into the potential benefits of this novel combination therapy for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 or older with advanced gastroesophageal adenocarcinoma and moderate HER2 expression who have not received prior systemic therapy.

Not a fit: Patients with HER2 expression levels outside the specified range or those who have received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced gastroesophageal adenocarcinoma, potentially improving survival rates and quality of life.

How similar studies have performed: While this approach is innovative, similar studies targeting HER2 in gastroesophageal cancers have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* At the same time, patients voluntarily participated in the study and signed informed consent;
* Either male or female, aged 18 or older;
* Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;
* No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
* HER2 IHC 2+ and FISH-;
* ECOG scores 0-1;
* Estimated survival ≥3 months;
* Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
* Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.

Exclusion Criteria:

* Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer;
* Known hypersensitivity to RC48-ADC;
* HBV DNA\>500 IU/ mL (or 2000 copies /ml), HCV RNA\>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
* History of HIV infection;
* History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment;
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Where this trial is running

Beijing and 2 other locations

• Beijing Friendship Hospital — Beijing, China (RECRUITING)
• Chinese PLA General Hospital — Beijing, China (RECRUITING)
• Chinese PLA General Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Ru Jia

Conditions: Advanced Gastroesophageal Adenocarcinoma