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A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04073602
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
RemeGen

Brief Summary:
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2-negative urothelial cancer.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative Metastatic or Unresectable Urothelial Cancer
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: RC48-ADC
Participants will be treated with RC48-ADC 2.0 mg/kg, once every 2 weeks (Q2W) until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Drug: RC48-ADC
The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.0 mg/kg, once every two weeks until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection




Primary Outcome Measures :
  1. Objective Response Rate (ORR)as assessed by Investigator [ Time Frame: 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. Progression Free Survival (PFS) [ Time Frame: 24 months ]
    Tumor response was assessed by investigator according to RECIST v1.1

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

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

  4. 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.

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • Predicted survival ≥ 12 weeks.
  • Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic urothelial cancer, originate from bladder, renal pelvis, ureter and urinary tract.
  • Unresectable or disease progression (i.e. locally advanced/metastasis) after surgery and at least regular chemotherapy including gemcitabine, cisplatin AND paclitaxel. Disease progression within 6 months of the completion of neo-adjuvant and adjuvant chemotherapy with gemcitabine, cisplatin AND paclitaxel is also eligible.
  • Measurable lesion according to RECIST 1.1.
  • HER2 negative (i.e. IHC -or 1+) as confirmed by the department of Pathology in Beijing Cancer Hospital. Subject is able to provide specimens from primary or metastatic lesions for HER2 tests.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:

Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9/L Platelets ≥ 100×10^9/L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN.

  • 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 the components of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate.
  • Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
  • Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
  • History of receiving any anti-cancer drug/biologic treatment within 3 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.
  • Currently known active infection with HIV or tuberculosis.
  • Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive.
  • 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 3 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.
  • Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
  • Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
  • NYHA Class III heart failure
  • Pregnancy or lactation.
  • 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): NCT04073602


Contacts
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Contact: Jianmin Fang +8610-58075763 jianminfang@hotmail.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100078
Contact: Jun Guo, M.D.         
Sponsors and Collaborators
RemeGen
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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT04073602    
Other Study ID Numbers: RC48-C011
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: June 2, 2020
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
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