A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT07401875
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- HC-7366
- Kidney Cancer
- Phase 1b
- SHARK
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGGiven by IV
- HC-7366 — DRUGGiven by po
- ipilimumab — DRUGGiven by IV
Study Details
To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The
Key Dates
- Start date
- Mar 24, 2026
- Status verified
- Mar 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2029
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Doublet CohortTreatment with Nivolumab + HC-7366 (PO) Q4W
- Experimental: Triplet CohortTreatment with Nivolumab + Ipilimumab + HC-7366 (PO) Q4W
Primary Outcome Measure
Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]
Central Contacts
- Eric Jonasch, MD713-563-7232
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | Eric Jonasch, MD (PRINCIPAL_INVESTIGATOR) |
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