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Advanced Urothelial CarcinomaPhase 1NCT07835035

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

A Phase 1 study testing Rimegepant and Toripalimab in people with Advanced Urothelial Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Urothelial Carcinoma
What is being tested?
Rimegepant and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesChina
Study dates
6 Jul 2026to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant voluntarily agrees to participate in this study, provides written informed consent, and is willing and able to comply with all study visits and the treatment plan.
  • Male or female participants aged ≥18 years.
  • Histologic or cytologic confirmation of locally advanced or metastatic urothelial carcinoma.
  • The participant's most recent standard therapy must have failed, and disease progression during or after treatment must be radiographically confirmed.
  • Standard therapies include, but are not limited to, platinum-containing chemotherapy regimens; programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) inhibitor monotherapy; or a PD-1/PD-L1 inhibitor in combination with chemotherapy or an antibody-drug conjugate (ADC).
  • Participants previously treated with a PD-1/PD-L1 inhibitor may be enrolled, except those who permanently discontinued such treatment because of an immune-related adverse event.
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  • At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • The most recent adequate archival tumor tissue specimen obtained within the previous 12 months must be provided as a formalin-fixed, paraffin-embedded block or serial unstained sections. Fresh tumor biopsies at baseline and at disease progression for exploratory biomarker research are strongly recommended but not required; a participant's decision whether to undergo biopsy will not affect eligibility for the main part of this clinical trial.
  • Estimated life expectancy of at least 6 months.
  • Eastern Cooperative Oncology Group (ECOG) score (PS) of 0 or 1.
  • Adequate major-organ function.

Who cannot join

  • History of a malignancy other than urothelial carcinoma, except in either of the following circumstances:
  • The prior malignancy was treated with potentially curative therapy and there has been no evidence of disease for 5 years.
  • Successfully resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or another carcinoma in situ.
  • Prior allogeneic stem-cell or solid-organ transplantation.
  • Current or prior congenital or acquired immunodeficiency disorder.
  • Known or suspected allergy to an anti-programmed cell death protein 1 (anti-PD-1) agent, history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to any excipient of either investigational product.
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  • Other clinically significant abnormalities in clinical status or laboratory test results that, in the investigator's opinion, may affect the safety assessment, such as uncontrolled diabetes mellitus, chronic kidney disease, Grade 2 or higher peripheral neuropathy according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0), or thyroid dysfunction.
  • An active or poorly controlled serious infection, including any of the following:
  • Positive for antibodies to human immunodeficiency virus type 1 or 2 (HIV-1/2).
  • Active hepatitis B, defined as hepatitis B surface antigen (HBsAg) positivity or hepatitis B virus (HBV) DNA >2,000 IU/mL accompanied by abnormal liver function.
  • Active hepatitis C, defined as hepatitis C virus (HCV) antibody positivity or HCV RNA ≥10³ copies/mL accompanied by abnormal liver function.
  • Active tuberculosis.
  • Any other uncontrolled active infection of Grade 3 or higher according to NCI CTCAE v6.0.
  • Failure to recover from surgery, such as the presence of an unhealed incision or serious postoperative complications.
  • Participants who are pregnant or breastfeeding, or female or male participants of reproductive potential who are unwilling or unable to use effective contraception.
  • Any other circumstance that the investigator considers unsuitable for enrollment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    Sujun Han, 010-67781331, hsj6686@sina.com

    Recruiting

  • Beijing Huanxing Cancer Hospital

    Beijing

    Linjun Hu, 010-87696652, hulinjun_001@163.com

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of the Safety and Preliminary Efficacy of Rimegepant Plus Toripalimab in Patients With Advanced Urothelial Carcinoma Following Failure of Standard Therapy

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.

Being tested
Rimegepant, Toripalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RimegepantDrug

    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.

  • ToripalimabBiological

    Toripalimab will be administered by intravenous infusion at a dose of 3.0 mg/kg every 2 weeks.

Study groups in NCT07835035
Study groupRoleWhat they receive
Rimegepant plus toripalimabExperimentalParticipants 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.
Receives: Drug: Rimegepant; Biological: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs)

    Occurrence of toxicity meeting the prespecified DLT criteria during the DLT observation period;

    Measured: From the first dose through Day 14

  2. Recommended Phase 2 dose (RP2D) of rimegepant in combination with toripalimab

    The recommended Phase 2 dose (RP2D) of rimegepant in combination with toripalimab will be determined based primarily on the occurrence of dose-limiting toxicities (DLTs), together with the overall safety and tolerability of the evaluated dose levels.

    Measured: From first participant enrollment through completion of the dose-escalation phase, up to 8 months

Secondary outcomes (2)

  1. Incidence and severity of adverse events and serious adverse events

    Number and proportion of participants experiencing adverse events (AEs) and serious adverse events (SAEs), including events leading to dose modification or treatment discontinuation. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0).

    Measured: From the first dose through 90 days after the last dose

  2. Radiographic progression-free survival (rPFS)

    Radiographic progression-free survival (rPFS): the time from the date of enrollment to radiographically confirmed disease progression or death from any cause, whichever occurs first. Radiographic disease progression will be determined by the investigator according to RECIST v1.1 based on assessment of the primary lesion, regional lymph node involvement, soft tissue metastases, and bone metastases.

    Measured: From enrollment until radiographic disease progression or death from any cause, whichever occurs first, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start6 Jul 2026
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07835035
Sponsor's protocol ID
26/304-6028
Other IDs
ChiCTR2600129019
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rimegepant and Toripalimab in people with Advanced Urothelial Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) (time frame: From the first dose through Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07835035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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