What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, particularly targeted therapies and immunotherapies, can have distinct side effects. Targeted therapies often cause fatigue, diarrhea, liver enzyme abnormalities, and skin reactions. Immunotherapies, such as PD-1 or PD-L1 inhibitors, can lead to immune-related adverse events, including colitis, pneumonitis, hepatitis, endocrinopathies, and skin toxicities. These side effects result from the immune system attacking normal tissues.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of esophageal cancer. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for use in patients with advanced or metastatic esophageal cancer, particularly those with high PD-L1 expression. Nivolumab, another PD-1 inhibitor, has also been approved for similar indications. These therapies work by targeting the PD-1/PD-L1 pathway to enhance the immune system's ability to fight cancer. Additionally, combination therapies involving these immunotherapies and chemotherapy have shown efficacy in clinical trials.

What other types of research exist?

Promising novel alternatives for esophageal cancer patients include: 1) Camrelizumab combined with chemotherapy, as shown in the ESCORT-1st trial, which demonstrated improved survival and progression-free survival in advanced or metastatic esophageal squamous cell carcinoma. 2) Pembrolizumab plus chemotherapy, as evidenced by the KEYNOTE-590 trial, which significantly prolonged overall survival and progression-free survival in patients with advanced unresectable or metastatic esophageal cancer.

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INCB099280 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.

Eastern Cooperative Oncology Group performance status score of 0 or 1.

Must not have

Clinically significant cardiac disease.

Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 25 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called INCB099280 to see if it is safe and effective for patients with certain types of solid tumors. Researchers want to understand how the drug behaves in the body and its early effects on cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the injection site, fatigue, nausea, changes in blood counts or chemistry that could affect organ function. Side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My advanced cancer can't be removed by surgery and has measurable growths.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have untreated or worsening brain metastases.

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I have previously received anti-PD-L1 therapy.

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I have or am at risk for hepatitis B or C reactivation.

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I am currently on medication for an infection.

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I am not taking probiotics and will not while in the study.

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I have been diagnosed with HIV.

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 25 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

AUC0-t of INCB099280

CL/F of INCB099280

Cmax of INCB099280

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

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

Group II: Cohort 2Experimental Treatment1 Intervention

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

Group III: Cohort 1Experimental Treatment1 Intervention

Participants with select solid tumors who are immunotherapy treatment-naive

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB099280

2024

Completed Phase 1

~10

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for esophageal cancer include targeted therapies and immunotherapies. Targeted therapies, such as those inhibiting HER2 (e.g., trastuzumab) and VEGF (e.g., ramucirumab), work by specifically targeting and blocking the growth signals of cancer cells, thereby inhibiting tumor growth and spread. Immunotherapies, such as PD-1 inhibitors (e.g., pembrolizumab and nivolumab), enhance the body's immune response against cancer cells by blocking the proteins that prevent immune cells from attacking the tumor. These treatments are significant for esophageal cancer patients as they offer more personalized and potentially more effective options compared to traditional chemotherapy, with the potential for fewer side effects and improved outcomes.