INCB081776 + INCMGA00012 for Cancer

No longer recruiting at 23 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Vitamin K antagonists, Corticosteroids

Disqualifiers: Retinal disease, Cardiac disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and early effects of two new drug treatments, either alone or in combination, for advanced cancers. Participants will receive either INCB081776 (an experimental treatment) alone or combined with INCMGA00012 (Retifanlimab, an immunotherapy drug) to evaluate their effectiveness against various cancers. This trial may suit individuals with advanced or metastatic cancer that hasn't responded to standard treatments, such as specific types of skin, lung, or soft-tissue cancers. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but it does exclude participants who have taken certain treatments like vitamin K antagonists, systemic corticosteroids, live vaccines, or anticancer medications within specific timeframes. It's best to discuss your current medications with the trial team.

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

Research has shown that INCB081776 remains in the early stages of testing, so limited safety information is available. However, some studies suggest it can slow tumor growth when combined with other treatments. This indicates potential safety, but more data is needed for confirmation.

When combined with INCMGA00012 (retifanlimab), more information is available. The FDA has approved retifanlimab for other uses, indicating general safety in past studies. Reports suggest it works well with chemotherapy and has a manageable safety profile, meaning side effects are usually not severe and can be controlled.

Overall, both treatments are still under study, and more safety information will emerge as research progresses. Current findings suggest they might be safe, especially when used with retifanlimab. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about INCB081776 and its combination with INCMGA00012 because these treatments represent a novel approach to cancer therapy. Unlike standard treatments like chemotherapy, which broadly attack fast-growing cells, INCB081776 targets specific proteins involved in cancer cell survival, potentially reducing harm to healthy cells. The combination with INCMGA00012, an immune checkpoint inhibitor, is particularly promising as it aims to enhance the body’s immune response against cancer, offering a dual-action strategy that could improve patient outcomes. Together, these treatments could provide a more targeted and potentially more effective alternative to traditional cancer therapies.

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

Research has shown that INCB081776, a treatment in this trial, holds promise for cancer therapy. It blocks proteins Axl and MerTK, which aid cancer growth. Studies have found that INCB081776 can slow tumor growth and enhance the body's immune response against cancer. Another treatment arm in this trial uses INCB081776 combined with INCMGA00012. Early results suggest that this combination more effectively tackles tumors. This trial tests how well this combination can prevent cancer from worsening. ^{1 2 3 6 7}

Who Is on the Research Team?

Diane Hershock, MD

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with advanced malignancies, including melanoma, lung cancer (NSCLC), head and neck cancer (SCCHN), soft-tissue sarcoma, and others. Participants must have measurable disease and may have received prior treatments as specified per cohort. They should be willing to undergo tumor biopsies but cannot join if they have significant heart issues, active autoimmune diseases requiring recent treatment, certain infections like hepatitis or HIV, or haven't recovered from previous therapy side effects.

Inclusion Criteria

I am 18 or older with advanced cancer and have tried or can't tolerate standard treatments.

I agree to have two biopsies of my tumor, one now and one during treatment.

Measurable disease per RECIST v1.1

Exclusion Criteria

I have a serious heart condition.

I am currently on medication for an infection.

History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB081776 as a single agent or in combination with INCMGA00012

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• INCB081776
• INCMGA00012

Trial Overview The study tests the safety and effectiveness of INCB081776 alone (Part 1) and combined with INCMGA00012 (Part 2). It will assess how these drugs are processed in the body and their impact on tumors. The trial aims to find out if these interventions can help treat various types of advanced cancers by monitoring early clinical activity.

How Is the Trial Designed?

Group I: INCB081776 + INCMGA00012 Experimental Treatment 2 Interventions

INCB081776 in combination with INCMGA00012.

Group II: INCB081776 Experimental Treatment 1 Intervention

Single-agent INCB081776.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10079616/

Dual Axl/MerTK inhibitor INCB081776 creates a pro ... Collectively, these data indicate that Axl/MerTK inhibition with INCB081776 results in a significantly hotter TIME in MOC2 tumors. INCB081776 and αPDL1 ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.27340

Dual Axl/MerTK inhibitor INCB081776 creates a ... INCB081776 treatment alone or with anti-PDL1 appears to slow MOC tumor growth, increase proinflammatory immune infiltration, and decrease anti-inflammatory ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03522142

NCT03522142 | A Study Exploring the Safety and ... The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36939040/

Dual Axl/MerTK inhibitor INCB081776 creates a ... - PubMed This data indicates that simultaneous targeting of Axl and MerTK with INCB081776, either alone or in combination with anti-PDL1, slows tumor growth and creates ...

5. synapse.patsnap.com synapse.patsnap.com/article/enhancing-tumor-immunity-the-role-of-incb081776-in-targeting-axlmer-kinases

The Role of INCB081776 in Targeting AXL/MER Kinases INCB081776 is a novel inhibitor targeting Axl and Mer kinases, which has been developed to impact both the tumor's malignant progression and ...

6. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/52063/pdf

A Phase 1a/1b Study Exploring the Safety and Tolerability ... This first-in-man study will investigate the safety and tolerability as well as establish a recommended dose of INCB081776 as a monotherapy ( ...

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.811247/full

The Development of AXL Inhibitors in Lung Cancer INCB081776 is a novel AXL/MER inhibitor that increases anti-tumor immune activity. In preclinical data, INCB081776 potently inhibited the ...