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Treatment for advanced or metastatic gastric cancer with HER2 overexpression

Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Gastric Cancer With HER2-overexpression

Phase 3 Interventional RemeGen Co., Ltd. · NCT04714190

This study is testing a new drug called RC48-ADC to see if it helps people with advanced stomach cancer that has a certain protein, after they have already tried other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment351 (estimated)
Ages18 Years and up
SexAll
SponsorRemeGen Co., Ltd. Industry-sponsored
Drugs / interventionschemotherapy
Locations52 sites (Beijing, Beijing and 51 other locations)
Trial IDNCT04714190 on ClinicalTrials.gov

What this trial studies

This Phase III, multicenter, randomized, open-label clinical trial evaluates the efficacy and safety of RC48-ADC, a monoclonal antibody-drug conjugate, compared to standard physician choice treatments for patients with HER2-overexpressing locally advanced or metastatic gastric cancer. Participants must have previously received at least two systemic chemotherapy regimens and have inoperable disease. The study aims to determine if RC48-ADC can provide better outcomes than existing treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with inoperable, advanced or metastatic gastric cancer who have experienced progression or intolerance after at least two prior chemotherapy treatments.

Not a fit: Patients with operable gastric cancer or those who have not received prior systemic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced gastric cancer that overexpresses HER2.

How similar studies have performed: Other studies have shown promising results with HER2-targeted therapies in gastric cancer, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
* Adequate organ function.
* All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma
* Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
* The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.
* HER2 classic positive (definition: IHC3+ or IHC2+FISH+) and patients who have previously failed standard treatment
* According to the RECIST 1.1 standard, there is at least one measurable lesion.

Exclusion Criteria:

* Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
* History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Where this trial is running

Beijing, Beijing and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastric CancerHER2 Overexpressing Gastric CarcinomaRC48-ADCHER2 overexpressionGastric cancer
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.