A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
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| ClinicalTrials.gov Identifier: NCT04714190 |
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Recruitment Status :
Recruiting
First Posted : January 19, 2021
Last Update Posted : January 10, 2022
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Sponsor:
RemeGen Co., Ltd.
Information provided by (Responsible Party):
RemeGen Co., Ltd.
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Brief Summary:
This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer HER2 Overexpressing Gastric Carcinoma | Drug: RC48-ADC Drug: Paclitaxel injection Drug: Irinotecan Hydrochloride Injection Drug: Apatinib Mesylate Tablets | Phase 3 |
This study is a phase III multi-center, randomized, open-label, parallel control study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2-overexpression locally advanced or metastatic gastric cancer. The HER2-overexpression is defined as: the HER2 IHC 3+ or 2+, regardless of FISH status.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 351 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 24, 2021 |
| Estimated Primary Completion Date : | July 1, 2022 |
| Estimated Study Completion Date : | December 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Stomach Cancer
| Arm | Intervention/treatment |
|---|---|
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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 |
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Active Comparator: Physician's Choice
Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
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Drug: Paclitaxel injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Name: Taxol Drug: Irinotecan Hydrochloride Injection Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Name: CAMPTO Drug: Apatinib Mesylate Tablets Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Name: Aitan |
Primary Outcome Measures :
- Overall survival (OS) [ Time Frame: within approximately 3 years ]Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Secondary Outcome Measures :
- Progression-free survival (PFS), evaluated by the investigator [ Time Frame: within approximately 3 years ]Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
- Objective remission rate (ORR) [ Time Frame: within approximately 3 years ]The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).
- Duration of relief (DOR) [ Time Frame: within approximately 3 years ]DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
- Disease control rate (DCR) [ Time Frame: within approximately 3 years ]Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
- Tumor progression time (TTP) [ Time Frame: within approximately 3 years ]Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
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): NCT04714190
Contacts
| Contact: Jianmin Fang, PhD | 010-58075561 | jianminfang@hotmail.com |
Locations
Show 52 study locations
Sponsors and Collaborators
RemeGen Co., Ltd.
| Responsible Party: | RemeGen Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT04714190 |
| Other Study ID Numbers: |
RC48-C007 |
| First Posted: | January 19, 2021 Key Record Dates |
| Last Update Posted: | January 10, 2022 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by RemeGen Co., Ltd.:
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RC48-ADC HER2 overexpression Gastric cancer |
Additional relevant MeSH terms:
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Paclitaxel Irinotecan Apatinib Trastuzumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Protein Kinase Inhibitors Antineoplastic Agents, Immunological |