Advanced Urothelial Carcinoma

13

Review clinical trials related to Advanced Urothelial Carcinoma. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy

This is a Phase II, single arm study. All subjects will receive Zanzalintinib 60 mg orally once daily until progression per RECIST 1.1 or intolerable toxicities or patient/investigator decision to discontinue study therapy. Radiology imaging will be performed every 8 weeks for 3 timepoints then every 12 weeks thereafter. A window of ± 7 days may be applied to all study visits to accommodate observed holidays, inclement weather, scheduling conflicts etc.

Participants needed: 44
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Guru SonpavdeUpdated: May 18, 2026
Eligibility criteria

Written informed consent and HIPAA authorization for release of personal health... [+23]

More than 3 lines of prior therapy (prior cisplatin-based perioperative chemothe... [+39]

Status: Recruiting

Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).

Participants needed: 96
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Apr 30, 2026Locations: 6
Eligibility criteria

Age ≥ 18 years; [+9]

Locally advanced patients who are candidates for curative local treatment; [+18]

Status: Recruiting

A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question\[s\] it aims to answer are: * Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab * What is the right dose level for patients Participants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans.

Participants needed: 120
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Flare Therapeutics Inc.Updated: Apr 20, 2026Locations: 12
Eligibility criteria

Able to understand and willing to sign an informed consent. [+5]

Female patients who are pregnant (confirmed with a positive pregnancy test) or b... [+70]

Status: Recruiting

Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma

This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled. Induction consists of EV (1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg/kg allowed) and P (200 mg IV on Day 1 of each cycle). Radiographic assessments occur after 3 and 6 cycles. Patients achieving complete or partial response transition to maintenance P (400 mg IV every 6 weeks or 200 mg IV every 3 weeks) for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for P. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients will enter long-term or survival follow-up as applicable.

Participants needed: 97
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Fox Chase Cancer CenterUpdated: Feb 19, 2026Locations: 1
Eligibility criteria

Patients must have histologically and radiographically confirmed locally advance... [+12]

Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-d... [+23]

Status: Not yet recruiting

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma. This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.

Participants needed: 100
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.Updated: Jan 29, 2026
Eligibility criteria

1. Patients aged 18-80 years (inclusive); [+8]

1.Active central nervous system metastases or leptomeningeal metastasis; [+4]

Status: Recruiting

A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma

To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.

Participants needed: 402
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.Updated: Jul 17, 2025Locations: 1
Eligibility criteria

Voluntarily participate in this clinical study, understand the study procedures... [+10]

Planned to receive any other anti-tumor therapy during this trial. [+23]

Status: Recruiting

Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma

This phase 1/2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.

Participants needed: 50
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Ekaterina LaukhtinaUpdated: Jun 26, 2025Locations: 1
Eligibility criteria

Patients with histologically or cytologically confirmed urothelial carcinoma, ra... [+13]

Received previous treatment with clofarabine [+12]

Status: Recruiting

A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer

The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.

Participants needed: 432
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Mabwell (Shanghai) Bioscience Co., Ltd.Updated: Apr 13, 2025Locations: 1
Eligibility criteria

Competent to comprehend, sign, and date an independent ethics committee/institut... [+11]

Chemotherapy or radiotherapy within 21 days prior to the first dose of study dru... [+15]

Status: Recruiting

Probiotics in Advanced Urothelial Carcinoma

This is a multicenter, randomized, controlled phase II Study of evaluating the efficacy and safety of immunotherapy combined with probiotics compound (Biolosion) in patients with advanced urothelial carcinoma.

Participants needed: 222
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Apr 1, 2025Locations: 3
Eligibility criteria

Aged 18 or above; [+8]

Patients with locally advanced disease may receive local radical treatment; [+17]

Status: Recruiting

A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.

Participants needed: 90
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.Updated: Nov 18, 2024Locations: 1
Eligibility criteria

Competent to comprehend, sign, and date an informed consent form. [+6]

Subjects with not adequately treated, or uncontrollable , or active CNS metastas... [+10]

Status: Recruiting

Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC

This is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasis(N+) status.

Participants needed: 60
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Peking University First HospitalUpdated: Nov 5, 2024Locations: 2
Eligibility criteria

1) Patients after radical nephroureterectomy with full-length nephroureterectomy...

1) Distant metastases already found at the time of surgery; non-R0 resected pati...

Status: Recruiting

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.

Participants needed: 100
Trial details
Phase: Phase 1, Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Mabwell (Shanghai) Bioscience Co., Ltd.Updated: Sep 19, 2024Locations: 1
Eligibility criteria

Sign and date the informed consent form e approved by independent ethics committ... [+10]

Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior... [+20]

Status: Recruiting

CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors

This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.

Participants needed: 94
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Northwestern UniversityUpdated: Mar 10, 2023Locations: 1
Eligibility criteria

Biliary [+35]

Patients who have not recovered from adverse events due to prior anti-cancer the... [+24]