Brief Title
A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate （ORR）
Secondary Outcome
ORR of HER2-positive patients
Condition
Urothelial Carcinoma
Intervention
RC48-ADC
Study Arms / Comparison Groups
RC48-ADC
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
43
Start Date
December 28, 2017
Completion Date
October 29, 2018
Primary Completion Date
October 29, 2018
Eligibility 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.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03507166
Organization ID
RC48-C005
Responsible Party
Sponsor
Study Sponsor
RemeGen Co., Ltd.
Study Sponsor
, ,
Verification Date
August 2019