What side effects are associated with this type of intervention?

Common treatments for colorectal cancer that involve immune modulation and enhance CD8 T-cell activity include immune checkpoint inhibitors like nivolumab and ipilimumab. Known side effects of these treatments can include immune-mediated colitis, skin reactions, endocrine events, and other immune-related adverse events such as pneumonitis and hepatitis. These side effects occur because the immune system is activated against not only cancer cells but also normal tissues, leading to inflammation and damage in various organs.

What prior FDA approvals exist?

The FDA has approved several immune-modulating therapies for colorectal cancer, particularly for cases with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors that enhance CD8 T-cell activity by targeting PD-1, a protein on T cells that normally helps keep these cells from attacking other cells in the body. These drugs have shown efficacy in treating MSI-H/dMMR colorectal cancer by boosting the immune system's ability to recognize and destroy cancer cells. Additionally, combination therapies such as nivolumab with ipilimumab (Yervoy), which targets CTLA-4, another checkpoint protein, have also been approved for this subset of colorectal cancer patients.

What other types of research exist?

Promising novel alternatives to INCB106385 for colorectal cancer patients include: 1) Pembrolizumab, a PD-1 inhibitor, which has shown efficacy in various cancers including CRC, especially in tumors with high microsatellite instability (MSI-H). 2) Nivolumab, another PD-1 inhibitor, often used in combination with other agents like ipilimumab for enhanced efficacy. 3) Relatlimab, a LAG-3 inhibitor, which can be combined with nivolumab to potentially improve outcomes in CRC. These therapies are in advanced stages of clinical trials and have shown promising results in enhancing CD8 T-cell activity.

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INCB106385 + Immunotherapy 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 28 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called INCB106385, alone or with INCMGA00012, in patients with advanced cancers that have CD8 T-cells. The goal is to enhance the immune system to fight the cancer more effectively.

Who is the study for?

This trial is for adults with certain advanced solid tumors that are CD8 T-cell-positive and have progressed after standard treatments. Participants must be in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, measurable disease, and agree to biopsies and contraception. Exclusions include recent vaccines, unmanaged immune-related toxicity or autoimmune diseases, active CNS metastases, other cancers within 2 years, unresolved treatment side effects, investigational drug use within recent weeks, significant heart issues or infections.

What is being tested?

The study tests INCB106385 alone or combined with immunotherapy INCMGA00012 on various advanced cancers. It's an early-phase trial assessing safety and how the body processes these drugs (pharmacokinetics), their impact on the body (pharmacodynamics), and initial effectiveness at different doses.

What are the potential side effects?

Potential side effects may include reactions related to the immune system affecting organs due to increased activity against cancer cells but also possibly targeting normal tissue; infusion reactions; changes in blood counts; fatigue; gastrointestinal disturbances like nausea or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 28 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

Number of treatment-emergent adverse events (TEAE)

Secondary study objectives

AUC of INCB106385 as a single agent or in combination with INCMGA00012

CL/F of INCB106385 as a single agent or in combination with INCMGA00012

Change in immune cell activation in tumors

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Group B (TGB) - INCB106385+INCMGA00012Experimental Treatment2 Interventions

In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.

Group II: Treatment Group A (TGA) - INCB106385Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB106385

2021

Completed Phase 1

~60

INCMGA00012

2021

Completed Phase 1

~60

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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

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as FOLFOX (oxaliplatin, leucovorin, and fluorouracil), works by killing rapidly dividing cancer cells. Targeted therapies, like bevacizumab, inhibit tumor angiogenesis, cutting off the blood supply to the tumor. Immunotherapy, particularly immune checkpoint inhibitors like those studied in the INCB106385 trial, enhances the activity of CD8 T-cells, which are crucial for attacking cancer cells. This immune modulation is significant for colorectal cancer patients as it can potentially lead to more effective and durable responses by harnessing the body's own immune system to fight the cancer.