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A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

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ClinicalTrials.gov Identifier: NCT03809013
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
RemeGen

Brief Summary:
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with HER2 overexpressing locally advanced or metastatic 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 : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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
2.0mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection




Primary Outcome Measures :
  1. Objective Response Rate (ORR)as assessed by the Independent Review Committee [ 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. 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)

  2. Progression Free Survival (PFS) [ Time Frame: 24 months ]
    PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first

  3. 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

  4. Disease control rate (DCR) [ Time Frame: 24 months ]
    DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)

  5. Overall survival (OS) [ Time Frame: 24 months ]
    OS was defined as the time from the first administration of study treatment to death from any cause.



Information from the National Library of Medicine

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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.
  • 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 overexpressing (i.e. IHC 2+ or 3+) as confirmed by the central lab. Primary or metastatic tumor sample will be provided for HER2 test.
  • 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 ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 × 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 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 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.
  • 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): NCT03809013


Contacts
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Contact: Jianming Fang +8610-58075763 jianminfang@hotmail.com
Contact: Na Su +8610-58075763 na.su@remegen.cn

Locations
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China, Anhui
Anhui Cancer Hospital Recruiting
Hefei, Anhui, China
Contact: Changlu Hu         
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100078
Contact: Jun Guo         
Principal Investigator: Jun Guo, Ph.D         
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
Contact: Aiping zhou         
Peking University First Hospital Recruiting
Beijing, Beijing, China
Contact: Zhisong He         
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Yanxia Shi         
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China
Contact: Weiqing Han         
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China
Contact: Benkang Shi         
China, Sichuan
West China Hospital Recruiting
Chendu, Sichuan, China
Contact: Jiyan Liu         
Sponsors and Collaborators
RemeGen
Investigators
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Principal Investigator: Jun Guo, Ph.D Beijing Cancer Hospital

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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT03809013     History of Changes
Other Study ID Numbers: RC48-C009
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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