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A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507166
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
RemeGen Co., Ltd.

Study Description
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Brief Summary:
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial cancer.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Advanced Cancer Drug: RC48-ADC Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Drug: RC48-ADC
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 Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
Actual Study Start Date : December 28, 2017
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arms and Interventions
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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).
 Drug: RC48-ADC
2 mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. ORR of HER2-positive patients [ Time Frame: up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1

  2. Progression Free Survival (PFS) [ Time Frame: up to 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1

  3. Duration of Response (DOR) [ Time Frame: up to 24 months ]
    DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier

  4. Disease control rate (DCR) [ Time Frame: up to 24 months ]
    DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study

  5. 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

  6. Adverse Events [ Time Frame: 28 days after the last dose of study treatment ]
    Incidence of Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (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 and < 80 years.
  • Predicted survival ≥ 12 weeks.
  • Have histologically or cytologically-confirmed diagnosis of inoperable, locally advanced or metastatic urothelial cancer of the bladder, renal pelvis, ureter.
  • Have had progression or intolerance following receipt of at least one systemic chemotherapy for advanced or metastatic disease.
  • Measurable disease according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
  • Adequate organ function, evidenced by the following laboratory results:

Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; Without liver metastasis: ALT and AST ≤ 2.5 x ULN; With liver metastasis: ALT and AST ≤ 5 x ULN; Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault equation.

  • 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.

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 receiving Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  • 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.
  • Currently known active infection with HIV or tuberculosis.
  • 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.
  • known central nervous system metastases.
  • Pregnancy or lactation.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Contacts and Locations
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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): NCT03507166


Locations
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China, N/A = Not Applicable
Beijing Cancer Hospital
Beijing, N/A = Not Applicable, China, 100078
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, N/A = Not Applicable, China
Sponsors and Collaborators
RemeGen Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: RemeGen Co., Ltd.
ClinicalTrials.gov Identifier: NCT03507166    
Other Study ID Numbers: RC48-C005
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RemeGen Co., Ltd.:
RC48-ADC
HER2
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents