Brief 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
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate （ORR）as assessed by the Independent Review Committee
Secondary Outcome
Objective Response Rate（ORR）as assessed by investigator
Condition
Urothelial Carcinoma
Intervention
RC48-ADC
Study Arms / Comparison Groups
RC48-ADC
Description: 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).
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
60
Start Date
January 7, 2019
Completion Date
December 31, 2022
Primary Completion Date
March 4, 2021
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jun Guo, Ph.D, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03809013
Organization ID
RC48-C009
Responsible Party
Sponsor
Study Sponsor
RemeGen Co., Ltd.
Study Sponsor
Jun Guo, Ph.D, Principal Investigator, Peking University Cancer Hospital & Institute
Verification Date
September 2021