INCB099280 for Cancer

No longer recruiting at 44 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Anticancer, Investigational, Probiotics, Antibiotics

Disqualifiers: Cardiac disease, Brain metastases, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment, INCB099280, to assess its safety and effectiveness for individuals with certain advanced solid tumors. It includes various groups: those who haven't tried immunotherapy, those with specific tumor markers (such as MSI-H or dMMR), and those whose cancer has progressed despite previous treatments. Suitable candidates are individuals with solid tumors that cannot be surgically treated and have exhausted all standard therapies but still experience disease progression. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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

The trial requires a 28-day period without taking systemic antibiotics before starting the study drug. Probiotics are not allowed during the study and screening. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that INCB099280 is likely to be safe for humans?

Research has shown that INCB099280 demonstrates promising safety results in studies with patients who have advanced solid tumors. These studies suggest that the treatment is generally well-tolerated at various doses. Most reported side effects were manageable and not severe. This ongoing research offers a positive outlook on the treatment’s safety for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about INCB099280 for cancer because it represents a fresh approach to treating solid tumors. Unlike most current therapies that target broad cancer pathways, INCB099280 works by specifically modulating the immune environment to enhance the body's natural ability to fight cancer. This targeted action could potentially improve outcomes for patients who have not responded well to existing treatments, such as traditional chemotherapy or other immunotherapies like PD-1 inhibitors. With its innovative mode of action, INCB099280 holds promise for providing a new line of defense against difficult-to-treat cancers.

What evidence suggests that INCB099280 might be an effective treatment for cancer?

Research shows that INCB099280, a PD-L1 inhibitor, shows early promise in treating advanced solid tumors. Studies report that it may help control tumor growth. Importantly, researchers have found it to be generally safe, meaning most patients tolerate it well. Unlike some similar drugs, INCB099280 has not been linked to severe nerve damage, which is a positive sign. These findings encourage those considering joining the trial, where participants will join different cohorts based on their tumor characteristics and previous treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors who have tried all other treatments without success or can't tolerate them. They should be relatively healthy otherwise, able to perform daily activities with ease (ECOG score of 0-1), and not planning to conceive. People with heart issues, untreated brain metastases, active infections, or recent use of certain drugs can't join.

Inclusion Criteria

My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.

Life expectancy > 12 weeks.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have a serious heart condition.

I have untreated or worsening brain metastases.

I haven't taken any cancer drugs or experimental medications recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB099280 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

Up to approximately 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 25 months

What Are the Treatments Tested in This Trial?

Interventions

• INCB099280

Trial Overview INCB099280 is being tested in this study. The goal is to see how safe it is for patients and how their bodies handle the drug (pharmacokinetics). Researchers also want to understand how the drug affects tumor biology (pharmacodynamics) and if it shows any signs of fighting the cancer.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy

Group II: Cohort 2 Experimental Treatment 1 Intervention

Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.

Group III: Cohort 1 Experimental Treatment 1 Intervention

Participants with select solid tumors who are immunotherapy treatment-naive

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2608

A phase 1 study of the small-molecule PD-L1 inhibitor ... INCB099280 has shown preliminary efficacy and acceptable safety in an ongoing phase 1, open-label, multicenter study in patients (pts) with advanced solid ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05879822

NCT05879822 | A Study to Evaluate INCB099280 in ... This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.

3. incytemi.com incytemi.com/document/Poster/ASCO%202024%20-%20INCB099280%20in%20Advanced%20Solid%20Tumors_Updated%20Results%20(poster).pdf

ASCO 2024 - INCB099280 in Advanced Solid ... ... INCB099280 in Select Advanced Solid Tumors: Updated Safety, Efficacy, and Pharmacokinetics Results. ○ Blockade of the programmed death ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04242199

Study Details | NCT04242199 | Safety, Tolerability, ... The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in ...

5. jitc.bmj.com jitc.bmj.com/content/10/suppl_2/a766

Abstract Unlike with the first-generation oral PD-L1 inhibitor INCB086550, no dose-limiting immune-mediated peripheral neuropathy has occurred to date with INCB099280.

6. esmoiotech.org esmoiotech.org/article/S2590-0188(23)00356-8/fulltext

159TiP Two phase I studies assessing the safety and ... INCB099280, an oral programmed death ligand 1 (PD-L1) inhibitor, has shown acceptable safety and preliminary efficacy in advanced solid tumors in an ongoing ...