A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
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ClinicalTrials.gov Identifier: NCT03556345 |
Recruitment Status :
Completed
First Posted : June 14, 2018
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer HER2 Overexpressing Gastric Carcinoma | Drug: RC48-ADC | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 127 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open Label,Single Arm,Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in HER2 Overexpressing Local Advanced or Metastatic Gastric Cancer |
Actual Study Start Date : | July 10, 2018 |
Actual Primary Completion Date : | June 1, 2020 |
Actual Study Completion Date : | August 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 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).
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Drug: RC48-ADC
2.5 mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection |
- Objective Response Rate (ORR) [ Time Frame: up to 24 months ]Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
- Progression Free Survival (PFS) as Assessed by investigator [ Time Frame: up to 24 months ]Tumor response was assessed by investigator according to RECIST v1.1
- Overall Survival(OS) [ Time Frame: up to 24 months ]OS was defined as the time from the first study treatment to the date of death from any cause

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556345
China, Beijing | |
Beijing Cancer Hospital | |
Beijing, Beijing, China, 100142 |
Responsible Party: | RemeGen Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03556345 |
Other Study ID Numbers: |
RC48-C008 |
First Posted: | June 14, 2018 Key Record Dates |
Last Update Posted: | January 13, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
RC48-ADC HER2 overexpression Gastric cancer |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Stomach Diseases Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |