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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 statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • UGN-501

    Biological/Vaccine

    UGN-501 is administered by intravesical instillation into the bladder. Participants receive 6 once-weekly instillations during the Induction Period. Participants eligible for maintenance receive 3 once-weekly instillations quarterly from Month 3 through Month 12.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: UGN-501 Dose Escalation (Part 1)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)

The number of participants with each type of event will be summarized.

Time frame
Up to 15 Months
2

Concentration of UGN-501 in blood and urine

Data will be summarized using descriptive statistics.

Time frame
Up to 12 Weeks
3

Complete response rate (CRR)

CRR is defined as the proportion of CIS participants who achieved CR at the Week 12 (3-month) Visit.

Time frame
3 Months
4

Recurrence-free survival (RFS) rate

RFS rate is defined as the proportion of participants with Ta/T1 disease who are recurrence-free at the 6-month Visit.

Time frame
6 Months

Secondary outcomes

1

Presence of anti-drug antibodies (ADA) in serum

The number of participants with ADA will be summarized.

Time frame
Up to 12 Weeks
2

UGN-501 maximum concentration (Cmax) following single and repeat dose administration

Data will be summarized using descriptive statistics

Time frame
Up to 12 Weeks
3

UGN-501 area under the concentration-time curve (AUC) following single and repeat dose administration

Data will be summarized using descriptive statistics.

Time frame
Up to 12 Weeks
4

UGN-501 terminal half-life (t1/2) following single and repeat dose administration

Data will be summarized using descriptive statistics.

Time frame
Up to 12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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