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

Phase 2

Completed

• Conditions: HER2 Overexpressing Gastric Carcinoma; Gastric Cancer
• Interventions: Drug: RC48-ADC

• Registration Number: NCT03556345
• Lead Sponsor: RemeGen Co., Ltd.

Brief Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-14
• Study Start: 2018-07-10
• Primary Completion: 2020-06-01
• Study Completion: 2020-08-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• Voluntary agreement to provide written informed consent.
• Male or female, Age ≥ 18 years and ≤ 80 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.
• Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
• HER2 overexpression defined as HER2 IHC 2+ or 3+.
• Measurable disease according to RECIST 1.1.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RC48-ADC	RC48-ADC	Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

Primary Outcome Measures

Name	Time	Method
Objective Response Rate （ORR）	up to 24 months	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	up to 24 months	OS was defined as the time from the first study treatment to the date of death from any cause
Progression Free Survival (PFS) as Assessed by investigator	up to 24 months	Tumor response was assessed by investigator according to RECIST v1.1

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China