Health TrialsbyHealthPanel

A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

ConditionsUrothelial CarcinomaHER2-expressing
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Expected survival ≥12 weeks.

Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.

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+.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RC48-ADC

    Drug

    2.0 mg/kg IV every 2 weeks

  • Toripalimab

    Drug

    3.0 mg/kg IV every 2 weeks

  • Gemcitabine

    Drug

    1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle

  • Cisplatin

    Drug

    70mg/m2 IV infusion on Day 1 of every 3 week cycle

  • Carboplatin

    Drug

    AUC=4.5, IV infusion on Day 1 of every 3 week cycle

Treatment groups

452 Participants
are divided into 2 treatment groups
Group A: RC48-ADC + JS001Experimental treatment 2 interventions
Group B: Gemcitabine + cisplatin/carboplatinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS), evaluated by independent review committee

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by independent review committee according to the RECIST 1.1 standard.

Time frame
Up to approximately 3 years
2

Overall survival (OS)

Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

Time frame
Up to approximately 3 years

Secondary outcomes

1

Objective remission rate (ORR)

The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).

Time frame
Up to approximately 3 years
2

Progression-free survival (PFS), evaluated by the investigator

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

Time frame
Up to approximately 3 years
3

Duration of relief (DOR)

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Time frame
Up to approximately 3 years
4

Disease control rate (DCR)

Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now