A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

Launched by REMEGEN CO., LTD. · Jan 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RC48-ADC for patients with advanced or metastatic gastric cancer that shows high levels of a protein called HER2. This trial is comparing RC48-ADC to the standard treatments that doctors usually prescribe. The goal is to see if RC48-ADC works better for patients whose cancer has either not responded to previous treatments or who have experienced side effects from them.

To participate in this trial, individuals must be at least 18 years old and have an advanced form of gastric cancer that cannot be surgically removed. They should have had at least two previous treatments that didn't work or caused problems. Participants should also be able to complete daily activities with minimal assistance and must agree to use effective birth control if they are of child-bearing age. If you join the trial, you will receive regular check-ups and monitoring to see how well the new treatment works for you. This study is currently recruiting participants, and it’s a chance to access a potentially helpful new therapy while contributing to important research.

Gender

ALL

Eligibility 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.