A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
NCT ID: NCT05302284
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
452 participants
INTERVENTIONAL
2022-06-14
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RC48-ADC + JS001
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).
RC48-ADC
2.0 mg/kg IV every 2 weeks
Toripalimab
3.0 mg/kg IV every 2 weeks
Gemcitabine + cisplatin/carboplatin
Participants will receive Gemcitabine + cisplatin or carboplatin every 3 weeks (Q3W) for maximum 6 weeks or until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Gemcitabine
1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle
Cisplatin
70mg/m2 IV infusion on Day 1 of every 3 week cycle
Carboplatin
AUC=4.5, IV infusion on Day 1 of every 3 week cycle
Interventions
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RC48-ADC
2.0 mg/kg IV every 2 weeks
Toripalimab
3.0 mg/kg IV every 2 weeks
Gemcitabine
1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle
Cisplatin
70mg/m2 IV infusion on Day 1 of every 3 week cycle
Carboplatin
AUC=4.5, IV infusion on Day 1 of every 3 week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Na Su, PhD
Role: STUDY_DIRECTOR
RemeGen Co., Ltd.
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Aiping zhou
Role: primary
Jun Guo
Role: primary
References
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Sheng X, Zeng G, Zhang C, Zhang Q, Bian J, Niu H, Li J, Shi Y, Yao K, Hu B, Liu Z, Liao H, Yu Z, Jin B, Zhao P, Yang T, Liu X, Qin Y, Xue X, Gou X, Huang J, Gu J, Qi X, Zhang L, Ma G, Liu B, Fang J, Jiang S, He Z, Zhou A, Guo J; RC48-C016 Trial Investigators. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. N Engl J Med. 2025 Oct 19. doi: 10.1056/NEJMoa2511648. Online ahead of print.
Other Identifiers
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RC48-C016
Identifier Type: -
Identifier Source: org_study_id