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).
Inclusion Criteria:
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.
Participants with high-grade Ta and/or T1 disease and/or CIS must meet one of the following criteria:
Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Participants with BCG-unresponsive disease also must be unwilling or unfit to undergo radical cystectomy.
Participants with low-grade disease must meet one of the following criteria:
All visible papillary tumors must be resected and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Participants with T1 disease should have a re-staging TURBT during Screening or within 6 weeks before Screening. Enhanced cystoscopy, such as blue light cystoscopy or other locally accepted modalities, is permitted, but the same modality must be used for all subsequent disease assessments.
Has Eastern Cooperative Oncology Group performance status score ≤2.
Has no concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma within the prostatic stroma. Freedom from upper tract disease, if clinically indicated, must be demonstrated by no evidence of upper tract tumor by either IV pyelogram, retrograde pyelogram, CT urogram with or without contrast, MRI urogram with or without contrast, or ureteroscopy with ureteral washing for cytology, performed within 6 months of enrollment. Participants with urothelial carcinoma involving the prostatic urethra, where carcinoma is confined to the ducts and/or epithelium, may be included after a restaging TURBT is performed to rule out more extensive disease involving the prostatic stroma.
Participants with prostate cancer may be eligible if, after surgery or radiation, they do not meet criteria for biochemical recurrence, or if they are on active surveillance at very low, low, or favorable risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤7, prostate-specific antigen <20 ng/dL, and cT1-cT2b, at the discretion of the investigator.
Has adequate organ and bone marrow function within 14 days of treatment initiation, as determined by routine laboratory tests:
Has a life expectancy >12 months.
Participants and participant partners must agree to follow contraception and barrier method requirements consistent with local regulations and the protocol during the study intervention period and for at least 12 weeks after the last study intervention instillation.
Has signed informed consent and is willing and able to comply with the requirements and restrictions listed in the informed consent form and protocol.
Exclusion Criteria:
heather.lansford@urogen.com610-226-5111
Dose escalation of UGN-501 in participants with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent low grade (LG) Ta and/or T1 disease.
Queen Creek, Arizona 85140, United States
apadavala@folioresearch.com480-525-7998
Philadelphia, Pennsylvania 19104, United States
CCaldasso@folioclinicalresearch.com661-310-1063
lguerrero@folioclinicalresearch.com951-677-3000 ext. 309
Nnamdi_Onochie@dfci.harvard.edu857-221-2468
kacie.flaherty@unmc.edu402-559-3834
harshil.sardhara@mountsinai.org908-449-1437
carusonn@upstate.edu315-464-5296
ryan.debarberie@pennmedicine.upenn.edu215-615-3780
hopeteam@startresearch.com843-839-1679
Keoisha.malone@objective.health615-523-9624
stephanie.sova@urologyaustin.com512-788-9688
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