Health Trials

A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC

ConditionsBladder (Urothelial, Transitional Cell) CancerNMIBCUrothelial Carcinoma BladderUrothelial Carcinoma in SituUrothelial Carcinoma RecurrentUrothelial Carcinoma of the Urinary BladderNon-Muscle Invasive Bladder CarcinomaNon-muscle Invasive Bladder Cancer (NMIBC)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.

About this trial

This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).

Eligibility criteria

Qualifiers

Participant must be 18 years of age or older at the time of signing informed consent.

Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and/or T1 disease and/or carcinoma in situ (CIS), or recurrent low-grade Ta and/or T1 disease.

persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy; or

recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy; or

Disqualifiers

Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma, including T2, T3, T4, and/or stage IV disease.

Current systemic therapy for bladder cancer.

Prior treatment with any human adenovirus-based therapy, such as nadofaragene firadenovec-vncg or cretostimogene grenadenorepvec.

Intravesical therapy within 4 weeks before starting study intervention, including but not limited to BCG, chemotherapy, and nogapendekin alfa inbakicept.

Trial design

Treatments tested in this trial

  • UGN-501

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.

Lead sponsor

Source ClinicalTrials.gov