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
192 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
To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The
CONDITIONS
Official 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...
- Able 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 per American Joint Committee on Cancer
- For triplet group: No prior systemic therapy for advanced RCC or prior adjuvant therapy allowed
- For doublet group: 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 as defined by RECIST 1.1
- Pathology confirmed RCC with extra tissue submitted if available
- Willing and able to undergo bone and brain scans at baseline and follow-up if positive
- Adequate organ function within 28 days prior to first dose including blood counts, kidney and liver function
- Women must not be breastfeeding during and for 5 months after treatment
- Women of childbearing potential must have a negative pregnancy test within 24 hours prior to first dose
- Women of childbearing potential and men must agree to use adequate contraception during the study and for specified weeks after last dose
- Participants with chronic hepatitis B must have undetectable viral load on therapy if indicated
- Participants with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Participants with treated brain metastases may be eligible if stable for at least 28 days without steroids
- Participants with prior or concurrent malignancy not interfering with study are eligible
- Participants with cardiac disease should have NYHA Class 2B or better
You will not qualify if you...
- For triplet group: Prior systemic treatment including immune checkpoint inhibitors or TKIs
- For doublet group: More than 3 prior systemic therapy lines allowed; recent kinase inhibitor within 2 weeks before study start
- Major surgery requiring general anesthesia within 28 days prior to first dose
- Radiosurgery, radiotherapy, or minor surgery within 14 days prior to first dose
- Active infection requiring systemic treatment
- Clinically significant active bleeding including hemoptysis
- Inability to swallow oral medication or poorly controlled gastrointestinal disorders affecting absorption
- Central nervous system metastasis unless stable and asymptomatic for at least 28 days without steroids
- Systemic corticosteroids (>10 mg prednisone or equivalent) or immunosuppressive treatments within 14 days prior to treatment
- Active autoimmune disease except specified controlled conditions
- Psychiatric or social conditions increasing risk or preventing consent or compliance
- Pregnant or breastfeeding women
- Participants receiving other investigational agents concurrently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric Jonasch, MD
CONTACT
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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