Actively Recruiting
A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-02
35
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
H
HiberCell, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and antitumor activity of combining HC-7366 with immunotherapy drugs nivolumab and ipilimumab in adults with advanced clear cell renal cell carcinoma, a type of kidney cancer. This Phase 1b study aims to assess two treatment combinations: HC-7366 with nivolumab alone and HC-7366 with both nivolumab and ipilimumab. The study focuses on safety by monitoring serious side effects and measuring tumor response rates using established criteria. Participants receive treatment either as a doublet regimen with HC-7366 taken orally every four weeks alongside intravenous nivolumab, or as a triplet regimen adding intravenous ipilimumab to the same schedule. The study evaluates these combinations for their ability to control cancer progression and also tracks the need for high-dose steroids due to side effects. Both treatment groups allow for close monitoring and adjustment based on response and safety. During the study, participants undergo various scans including bone and brain imaging to monitor disease status. Laboratory tests assess organ function and blood counts before and during treatment. Researchers collect tissue samples for analysis and use questionnaires to evaluate participant-reported health outcomes. The primary outcome is safety over about one year, with secondary outcomes including survival and quality of life measures. Participants remain under observation for disease control and adverse events throughout the study duration.
CONDITIONS
Brief Title
A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Male or female aged 18 years or older
- Confirmed diagnosis of clear cell renal cell carcinoma
- Stage IV metastatic renal cell carcinoma
- Triplet Cohort: No prior systemic therapy for advanced disease or prior adjuvant therapy allowed
- Doublet Cohort: Must have progressed on at least one PD1-based doublet regimen; prior adjuvant therapy counts as one line
- ECOG performance status of 0 or 1
- At least one measurable tumor lesion per RECIST 1.1
- Pathology-confirmed renal cell carcinoma with tissue available for analysis
- Willing and able to undergo bone and brain scans at baseline and if positive
- Adequate organ function within 28 days prior to first dose
- Women not breastfeeding during treatment and up to five months after last dose
- Women of childbearing potential must have negative pregnancy test within 24 hours before treatment start
- Women of childbearing potential must agree to use acceptable contraception before and during study and for 23 weeks after last dose
- Men sexually active with women of childbearing potential must agree to use contraception before and during study and for 31 weeks after last dose
- Participants with chronic hepatitis B must have undetectable viral load on suppressive therapy
- Participants with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Participants with previously treated brain metastases must be stable for at least 4 weeks with no new or enlarging lesions
- Participants with prior or concurrent malignancy not interfering with study assessment are eligible
- Participants with cardiac disease should have NYHA Functional Class 2B or better
You will not qualify if you...
- Triplet Cohort: Prior systemic treatment including immune checkpoint inhibitor or tyrosine kinase inhibitor
- Doublet Cohort: More than 3 prior lines of systemic therapy
- Received small molecule kinase inhibitor within 2 weeks before study start
- Major surgery within 28 days before first dose
- Radiosurgery, radiotherapy, or minor surgery within 14 days before first dose
- Active infection requiring systemic treatment
- Active significant bleeding including hemoptysis
- Inability to swallow oral medication or uncontrolled gastrointestinal disorders affecting absorption
- CNS metastasis unless asymptomatic and stable for at least 4 weeks without steroids
- Systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressive meds within 14 days before treatment
- Active autoimmune disease except certain controlled conditions
- Known psychiatric or medical conditions increasing risk or impairing consent or compliance
- Pregnant or breastfeeding women
- Receiving other investigational agents concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive treatment with either Nivolumab plus HC-7366 or Nivolumab, Ipilimumab, and HC-7366 in repeated 4-week cycles.
Visits every 4 weeks during treatment
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric Jonasch, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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