HC-7366 + Nivolumab for Kidney Cancer

EJ
Overseen ByEric Jonasch, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of drugs—specifically HC-7366 (an experimental treatment) and nivolumab, with or without ipilimumab—can help control clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. The researchers aim to determine if these drugs together can better manage the cancer's progression. Participants diagnosed with stage IV metastatic ccRCC, who have either not received prior treatment or have experienced cancer progression after certain treatments, may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments like small molecule kinase inhibitors, you may need to stop them at least 2 weeks before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is testing the safety and effectiveness of combining HC-7366 and nivolumab for treating kidney cancer. Earlier studies have examined HC-7366 with other treatments, such as belzutifan, focusing on safety and patient tolerance. These studies are in the early stages, so researchers are still learning about its safety.

More information is available about the combination of nivolumab and ipilimumab. This combination has received approval in some places for treating certain types of kidney cancer, suggesting it is generally well-tolerated. However, researchers are still exploring the safety of adding HC-7366 to this mix.

Keep in mind that early-stage research provides limited information on long-term safety. Participants in these trials help provide more information about the potential effectiveness and safety of these treatments.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because HC-7366, when combined with Nivolumab and potentially Ipilimumab, may offer a fresh approach for kidney cancer. Unlike standard treatments that often focus solely on immune checkpoint inhibitors like Nivolumab or Ipilimumab, HC-7366 could introduce a novel mechanism to bolster the immune response against cancer cells. This combination might enhance the effectiveness of the treatments, potentially leading to improved outcomes for patients. The unique aspect of HC-7366 being administered orally (PO) also offers a different delivery method that could improve patient convenience and compliance.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

Research shows that using HC-7366 with nivolumab might help manage clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. HC-7366 reduces certain proteins that cancer cells need, potentially slowing the cancer's growth. Nivolumab enhances the immune system's ability to fight cancer. In this trial, participants in the Doublet Cohort will receive treatment with nivolumab and HC-7366.

Additionally, studies have found that combining nivolumab with ipilimumab, another immune-boosting drug, can lead to better long-term results in kidney cancer. This trial also includes a Triplet Cohort, where participants will receive nivolumab, ipilimumab, and HC-7366. This suggests that adding ipilimumab to HC-7366 and nivolumab could provide extra benefits. These treatments aim to strengthen the body's natural defenses against cancer cells, offering hope for better management of kidney cancer.12367

Who Is on the Research Team?

EJ

Eric Jonasch, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced clear cell renal cell carcinoma (ccRCC), which is a type of kidney cancer. Participants must have measurable stage IV metastatic RCC and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Prior treatments vary: no systemic therapy for the Triplet Cohort; at least one failed PD1-based regimen for the Doublet Cohort.

Inclusion Criteria

I have not had any treatment for advanced kidney cancer before.
My kidney cancer is at stage IV.
I meet the specific requirements needed to participate.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HC-7366 with nivolumab (and ipilimumab for the triplet cohort) to assess safety and antitumor activity

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • HC-7366
  • Ipilimumab
  • Nivolumab

Trial Overview

The study tests HC-7366, an immune system activator, combined with nivolumab, an immunotherapy drug (and possibly ipilimumab in some cases). It aims to control ccRCC by enhancing the body's immune response against cancer cells. The trial will assess if this combination can manage kidney cancer more effectively than current treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Triplet CohortExperimental Treatment3 Interventions
Group II: Doublet CohortExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

HiberCell, Inc.

Industry Sponsor

Trials
20
Recruited
860+

Citations

Kidney Cancer Research Updates for the Entire Clinical ...

Long-term efficacy observed with combination nivolumab plus cabozantinib vs sunitinib · Safety and tolerability were management and consistent ...

A phase 1b, open-label, safety, tolerability, and efficacy ...

These preclinical effects of HC-7366 suggest potential therapeutic benefit in clear cell renal cell carcinoma (ccRCC) and rationale for ...

Combination Regimens Offer Options in Frontline RCC as ...

The 60-month PFS rates were 13.6% and 3.6%, respectively. The median OS was 46.5 months (95% CI, 40.6-53.8) and 35.5 months (95% CI, 29.2-42.8), ...

HC-7366 + Nivolumab for Kidney Cancer

It aims to control ccRCC by enhancing the body's immune response against cancer cells. The trial will assess if this combination can manage ...

Emerging innovative treatment strategies for advanced clear ...

This article reviews key findings that have transformed the way we understand and treat metastatic renal cell carcinoma and highlights novel ...

5 A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy ...

HC-7366, a potent GCN2 activator, complements belzutifan, a HIF-2⍺ antagonist, by providing combination benefit in belzutifan-sensitive models and monotherapy ...

UCSD Renal Cell Carcinoma Clinical Trials for 2026

This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™).