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Phase 1bPhase 1NCT07401875

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

A Phase 1 study testing Nivolumab, HC-7366 and ipilimumab in people with Phase 1b and HC-7366, run by M.D. Anderson Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Phase 1b, HC-7366, SHARK
What is being tested?
Nivolumab, HC-7366 and ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesUnited States
Study dates
24 Mar 2026to 30 Nov 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 1. For the Triplet Cohort (Nivo/Ipi/HC-7366):
  • Prior systemic treatment including neoadjuvant or adjuvant therapy including an immune checkpoint inhibitor or TKI 2. For the Doublet Cohort (Nivo/HC-7366):
  • No more than 3 prior lines of systemic therapy allowed
  • Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤ 2 weeks before start of study drug or study therapy 3. ≤ 28 days before first dose of protocol-indicated treatment:
  • Major surgery requiring general anesthesia 4. ≤ 14 days before first dose of protocol-indicated treatment:
  • Radiosurgery or radiotherapy
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  • Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
  • Active infection requiring systemic treatment 5. Known or suspected clinically significant active bleeding including active hemoptysis 6. Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug - e.g. Crohn's disease, ulcerative colitis, chronic diarrhea (defined as > 4 loose stools per day), malabsorption, or bowel obstruction 7. Central nervous system (CNS) metastasis, unless asymptomatic and radiologically (by MRI) and clinically stable (i.e., without evidence of disease progression) for at least 4 weeks (28 days) by repeat imaging (repeat imaging should be performed during study screening), with no evidence of new or enlarging brain metastases, and without requirement for steroid treatment for at least 28 days prior to the first dose of study drug or study therapy. (CT is acceptable if MRI is contraindicated 8. Any condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment
  • In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intraarticular, intranasal, and inhalational) ≤ 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg/day prednisone or equivalent daily (e.g. hormone replacement therapy needed in participants with hypophysitis) 9. Active, known or suspected autoimmune disease
  • Subjects with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll 10. Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements 11. Pregnant women are excluded from this study because HC-7366 is novel, first-in-class small molecule agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with HC-7366, breastfeeding should be discontinued if the mother is treated with HC-7366. These potential risks may also apply to other agents used in this study 12. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this study 13. Participants who are receiving any other investigational agents

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Jonasch, MD contact

713-563-7232

ejonasch@mdanderson.org

United States2 sites, 2 recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Hans Hammers, MD, 214-645-7445, hans.hammers@utsouthwestern.edu

    Hans Hammers, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Eric Jonasch, MD, 713-563-7232, ejonasch@mdanderson.org

    Eric Jonasch, MD

    Recruiting

Other trials in United States

About this study

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

Read 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.

Being tested
Nivolumab, HC-7366, ipilimumab
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07401875
Study groupRoleWhat they receive
Doublet CohortExperimentalTreatment with Nivolumab + HC-7366 (PO) Q4W
Receives: Drug: Nivolumab; Drug: HC-7366
Triplet CohortExperimentalTreatment with Nivolumab + Ipilimumab + HC-7366 (PO) Q4W
Receives: Drug: Nivolumab; Drug: HC-7366; Drug: ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start24 Mar 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07401875
Sponsor's protocol ID
2025-1590
Other IDs
NCI-2026-00890
Status last verified
Sep 2026
First submitted
5 Feb 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab, HC-7366 and ipilimumab in people with Phase 1b and HC-7366, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Jonasch, MD (713-563-7232, ejonasch@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07401875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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