N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT07217496
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nogapendekin Alfa Inbakicept (NAI) — DRUG
    1.2mg given subcutaneously (SC) every 3 weeks, for a maximum of 35 cycles (2 years). Known HIV-positive participants will receive a weight-based dose of 6 µg/kg
  • enfortumab vedotin (EV) — DRUG
    1.25 mg/kg given intravenously (IV) on Day 1 and Day 8 of each 3-week cycle, for approximately 5.5 to 8 months (8 to 12 cycles), but no more than 12 cycles.
  • Pembrolizumab — DRUG
    200 mg given intravenously (IV) every 3 weeks, for a maximum of 35 cycles (2 years)

Study Details

This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).

Key Dates

First listed
Oct 16, 2025
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Participants will start combined treatment with EV/Pembrolizumab (P) and NAI. Treatment will consist of up to 12 cycles of EV and up to 35 cycles of NAI and pembrolizumab (2 years).

Primary Outcome Measure

Assess the safety and tolerability of the treatment regimen (NAI, EV, and pembrolizumab). [ Time Frame: From the date of first dose of study product to 30 days after the last dose of study product. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Genitourinary Medical Oncology Recruitment
[email protected]
877-827-3222

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