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Incb099280

Clinical trials are studying Incb099280 in people with advanced solid tumors, cutaneous squamous cell carcinoma, and KRASG12C-mutated solid tumors. These studies look at safety, tolerability, and early signs of benefit, both alone and in combination with other cancer medicines.

Table of contents

Clinical trials overview

The trial data show four interventional studies of Incb099280 in people with cancer.[1][2][3][4] Two were Phase 2 studies and two were Phase 1 studies.[1][2][3][4] All four trials are marked as completed.[1][2][3][4]

Who was studied

One Phase 2 study looked at people with recurrent or advanced/metastatic solid tumors who were immunotherapy-naïve, meaning they had not received immunotherapy before.[1] Another Phase 2 study focused on people with advanced cutaneous squamous cell carcinoma, including previously untreated or recurrent locally advanced or metastatic disease that was not suitable for curative surgery or radiotherapy.[3]

The Phase 1 combination study with adagrasib enrolled adults with advanced solid tumors harboring a KRASG12C mutation.[2] The Phase 1 study with ipilimumab included participants with selected solid tumors.[4] In simple terms, these studies focused on adults with cancers that were already advanced and needed new treatment options.[1][2][3][4]

What the trials measured

The Phase 2 studies measured objective response, which means whether the cancer shrank in a confirmed way.[1][3] They used standard response rules such as RECIST v1.1, and one study also used composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.[1][3]

All studies tracked treatment-emergent adverse events (TEAEs), which are side effects or medical problems that happen after treatment starts.[1][2][3][4] They also looked at how often these events caused dose interruption, dose reduction, or stopping the study drug.[1][2][3][4] The safety checks included physical exams, vital signs, electrocardiograms, and laboratory tests.[1][3]

The Phase 1 combination studies also measured dose-limiting toxicities (DLTs), which are side effects severe enough to limit dosing.[2][4] One of these studies aimed to find the maximum tolerated dose (MTD) or one or more recommended dose(s) for expansion (RDEs), while the other aimed to identify one or more RDEs.[2][4] In patient terms, these outcomes help researchers decide what dose can be given safely and what dose should be studied next.[2][4]

Study phases and treatment plans

The two Phase 2 studies tested Incb099280 as a single oral treatment at 400 mg BID, 600 mg BID, and 800 mg BID, according to the study summaries.[1][3] These studies were designed to learn about safety, tolerability, and early signs of benefit in larger patient groups.[1][3]

The Phase 1 studies tested Incb099280 in combination with other cancer medicines.[2][4] One study combined it with adagrasib, and the other combined it with ipilimumab.[2][4] These early studies focused on safety and dose finding before any larger testing could happen.[2][4]

Completed studies at a glance

The largest study in the data set enrolled 328 participants and studied recurrent or advanced/metastatic solid tumors in immunotherapy-naïve people.[1] The advanced cSCC Phase 2 study enrolled 241 participants.[3] The Phase 1 adagrasib combination study enrolled 125 participants, and the Phase 1 ipilimumab combination study enrolled 124 participants.[2][4]

Together, these studies show that research on Incb099280 has centered on advanced cancer settings, especially solid tumors and cutaneous squamous cell carcinoma.[1][2][3][4] The main questions were whether treatment was safe, how well it was tolerated, what dose could be used, and whether the cancer showed a response.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2022-502716-37-00 Phase 2 Recurrent or advanced/metastatic solid tumors in immunotherapy-naïve participants Completed 328
2023-503223-26-00 Phase 1 Advanced solid tumors with KRASG12C mutation Completed 125
2022-502476-23-00 Phase 2 Advanced cutaneous squamous cell carcinoma Completed 241
NCT05909995 Phase 1 Selected solid tumors Completed 124

FAQ

  • What is being studied in the Incb099280 trials? The trials are testing Incb099280 in people with certain advanced cancers. Some studies look at it alone, and others study it with adagrasib or ipilimumab.
  • Who may join these studies? The target groups include adults with advanced solid tumors, immunotherapy-naïve participants, people with advanced cutaneous squamous cell carcinoma, and adults with KRASG12C-mutated solid tumors. Each trial has its own entry rules.
  • What phases are the Incb099280 trials? The data include Phase 1 and Phase 2 studies. Phase 1 trials focus mainly on safety and dose finding, while Phase 2 trials also look at early treatment effect.
  • What results are the trials measuring? The studies measure objective response, which means whether the cancer shrinks in a confirmed way. They also measure treatment-emergent adverse events, or side effects that appear during the study, and how often these side effects lead to dose changes or stopping treatment.
  • Are the Incb099280 trials still recruiting? All of the trials listed here are marked as completed. That means they are no longer taking new participants.

Ongoing Clinical Trials on Incb099280

  • Study of INCB099280 and Adagrasib for Adults with Advanced Solid Tumors with KRASG12C Mutation

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study of INCB099280 for Patients With Advanced Cutaneous Squamous Cell Carcinoma Not Suitable for Surgery or Radiotherapy

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Croatia Finland France Hungary The Netherlands Romania +1

  • Study of INCB099280 and Ipilimumab for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Slovakia Sweden

  • Study of INCB099280 for Patients with Advanced Solid Tumors Who Have Not Received Immunotherapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary Romania

Glossary

  • Advanced solid tumors: Cancer that has grown beyond the original site and is no longer considered early stage.
  • Metastatic: Cancer that has spread to other parts of the body.
  • Locally advanced: Cancer that has grown more widely in the area where it started, but may not have spread far away.
  • Cutaneous squamous cell carcinoma (cSCC): A type of skin cancer that starts in the flat cells on the skin surface.
  • Immunotherapy-naïve: A person who has not yet received immunotherapy, which is a treatment that helps the immune system fight cancer.
  • KRASG12C mutation: A specific change in a cancer gene. Trials may focus on this change because it can help define a group of patients for study.
  • Phase 1: An early trial phase that mainly checks safety, side effects, and dose selection.
  • Phase 2: A later early-phase study that looks at safety and whether the treatment shows signs of helping.
  • Objective response: A measured sign that the cancer has shrunk, such as a complete response or partial response.
  • RECIST v1.1: A standard way to measure tumor response on scans in solid tumor studies.
  • Treatment-emergent adverse events (TEAEs): Side effects or medical problems that happen after treatment starts.
  • Dose-limiting toxicities (DLTs): Side effects severe enough to limit how much of a treatment can be given.

References

  1. https://clinicaltrials.gov/study/2022-502716-37-00
  2. https://clinicaltrials.gov/study/2023-503223-26-00
  3. https://clinicaltrials.gov/study/2022-502476-23-00
  4. https://clinicaltrials.eu/trial/study-of-incb099280-and-ipilimumab-for-patients-with-advanced-solid-tumors/