Rimegepant Plus Toripalimab in Advanced Urothelial Carcinoma After Failure of Standard Therapy

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07835035
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Rimegepant will be administered orally in a dose-escalation design. At dose level 1, participants will receive rimegepant 75 mg every other day. If dose level 1 is considered tolerable according to the prespecified dose-limiting toxicity criteria, dose escalation will proceed to dose level 2, in which participants will receive rimegepant 75 mg once daily. Rimegepant will be administered in combination with toripalimab.
  • Toripalimab — BIOLOGICAL
    Toripalimab will be administered by intravenous infusion at a dose of 3.0 mg/kg every 2 weeks.

Study Details

This multicenter, open-label, single-arm exploratory study will evaluate the safety, tolerability, and preliminary antitumor activity of rimegepant in combination with toripalimab in patients with locally advanced or metastatic urothelial carcinoma after failure of prior standard therapy. Approximately 6 to 12 participants will be enrolled. The primary objectives are to assess dose-limiting toxicities and other safety outcomes and to determine the recommended Phase 2 dose (RP2D) of rimegepant when combined with toripalimab. The study will also explore preliminary antitumor activity and selected biomarkers, including changes in the tumor immune microenvironment and circulating tumor DNA. The study is designed to determine whether targeting calcitonin gene-related peptide (CGRP) signaling with rimegepant can be safely combined with programmed cell death protein 1 (PD-1) blockade using toripalimab and whether this combination shows evidence of antitumor activity in patients with advanced urothelial carcinoma who have progressed after standard treatment.

Key Dates

First listed
Sep 22, 2026
Start date
Jul 6, 2026
Status verified
Sep 2026
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rimegepant plus toripalimab
    Participants will receive rimegepant in combination with toripalimab in a dose-escalation design. At dose level 1, rimegepant will be administered orally at 75 mg every other day, together with toripalimab 3 mg/kg by intravenous infusion every 2 weeks. If dose level 1 is considered tolerable according to the prespecified dose-limiting toxicity criteria, enrollment will proceed to dose level 2, in which rimegepant will be administered orally at 75 mg once daily with toripalimab 3 mg/kg every 2 weeks.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From the first dose through Day 14 ]

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