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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma Advanced Cancer||Drug: RC48-ADC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Drug: RC48-ADC|
|Masking:||None (Open Label)|
|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|
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).
2 mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
- 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)
- ORR of HER2-positive patients [ Time Frame: up to 24 months ]Tumor response was assessed by investigator according to RECIST v1.1
- Progression Free Survival (PFS) [ Time Frame: up to 24 months ]Tumor response was assessed by investigator according to RECIST v1.1
- 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
- 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
- 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
- Adverse Events [ Time Frame: 28 days after the last dose of study treatment ]Incidence of Adverse Events
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.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Responsible Party:||RemeGen Co., Ltd.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological