NCT07401875

A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The

Detailed description

Primary Objectives To assess two combinations of HC-7366: * Doublet Cohort: HC-7366 with nivolumab monotherapy * Triplet Cohort: HC-7366 with nivolumab/ipilimumab dual immune checkpoint inhibition * For safety through assessment of trial-limiting toxicities including need for high dose corticosteroids (= 40 mg prednisone equivalents for two weeks or more) * For antitumor activity through assessment of Overall response rate (ORR) and Disease control rate (DCR: CR or partial response (PR) or stable disease (SD)) per RECIST v1.1 Secondary Objectives The secondary objectives of the study are to estimate median progression free survival (mPFS) and PFS at six months, duration of response (DOR), primary PD rate (progressive disease as best response), Time to response (TTR), overall survival (OS) median and at one year, immune related Adverse Event (irAE) rate, and to evaluate participant reported outcomes using the FKSI-23 and the FACT-ICM Subscale.

Conditions

• Phase 1b
• HC-7366
• SHARK
• Kidney Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Given by IV
DRUG	HC-7366	Given by po
DRUG	ipilimumab	Given by IV

Timeline

• Start date: 2026-03-24
• Primary completion: 2027-11-30
• Completion: 2029-11-30
• First posted: 2026-02-11
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study