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

Eligibility Criteria

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

Interventions

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 Cohort
    Treatment with Nivolumab + HC-7366 (PO) Q4W
  • Experimental: Triplet Cohort
    Treatment 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

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Eric Jonasch, MD
713-563-7232
Eric Jonasch, MD (PRINCIPAL_INVESTIGATOR)

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