Brief Title
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Official Title
A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing
Brief Summary
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare
RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated
HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.
Detailed Description
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study to evaluate the
efficacy and safety of RC48-ADC,a recombinant humanized anti-HER2 monoclonal
antibody-Monomethyl auristatin E (MMAE) conjugate, in Combination With JS001,a PD-1
monoclonal antibody, for the treatment of Previously Untreated HER2-Expressing Unresectable
Locally Advanced or Metastatic Urothelial Carcinoma.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival (PFS), evaluated by independent review committee
Secondary Outcome
Objective remission rate (ORR)
Condition
Urothelial Carcinoma
Intervention
RC48-ADC
Study Arms / Comparison Groups
RC48-ADC + JS001
Description: Participants will receive RC48-ADC + JS001 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
452
Start Date
June 14, 2022
Completion Date
April 30, 2028
Primary Completion Date
December 31, 2026
Eligibility Criteria
Inclusion Criteria:
- Expected survival ≥12 weeks.
- Locally advanced unresectable or metastatic UC with histopathological confirmation,
including UC originating from the renal pelvis, ureters, bladder, or urethra.
- Participants must not have received prior systemic therapy for locally advanced or
metastatic urothelial carcinoma with the following exceptions:
Participants that received neoadjuvant chemotherapy with recurrence >6 months from
completion of therapy are permitted; Participants that received adjuvant chemotherapy
following cystectomy with recurrence >6 months from completion of therapy are permitted.
- At least one measurable lesion based on RECIST version 1.1
- HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.
- ECOG performance status score: 0 or 1.
- Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.
Exclusion Criteria:
- Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.
- History of major surgery within 4 weeks of planned start of trial treatment.
- Toxicity from a previous treatment has not returned to Grade 0-1.
- Prior ADCs or PD-1/PD-L1 inhibitor therapy.
- Active central nervous system (CNS) metastases.
- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV)
infection.
- History of other malignancy within the previous 5 years, except for low-risk localized
prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma
skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- Other serious, uncontrolled concomitant diseases that may affect protocol compliance
or interpretation of outcomes, including active opportunistic infections or advanced
(severe) infections, or uncontrolled diabetes.
- Active autoimmune diseases that require systemic therapy over the past 2 years.
Replacement therapies (such as thyroxine, insulin, or physiological replacement of
glucocorticoids due to renal or pituitary deficiency) are allowed.
- 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
Na Su, PhD, +86-010-58075561, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05302284
Organization ID
RC48-C016
Responsible Party
Sponsor
Study Sponsor
RemeGen Co., Ltd.
Study Sponsor
Na Su, PhD, Study Director, RemeGen Co., Ltd.
Verification Date
August 2022