What is the mechanism of action of this treatment?

Targeted therapies and small molecule inhibitors, such as those being studied in the trial INCB161734, work by specifically targeting molecular pathways that are essential for tumor growth and survival. These treatments often inhibit proteins or enzymes that are mutated or overexpressed in cancer cells, such as kinases involved in cell signaling pathways. By blocking these critical pathways, targeted therapies can effectively halt tumor progression and induce cancer cell death while minimizing damage to normal cells. This precision makes them particularly valuable for patients with solid tumors, as they offer a more tailored and potentially less toxic treatment option compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common side effects of targeted therapies and small molecule inhibitors for solid tumors include fatigue, nausea, diarrhea, and skin reactions such as rash. Other potential side effects can include hypertension, liver toxicity, and hematologic abnormalities like neutropenia and thrombocytopenia. These treatments aim to specifically target cancer cells, but they can also affect normal cells, leading to these adverse effects.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and small molecule inhibitors for the treatment of solid tumors. Notable examples include pembrolizumab, an anti-PD-1 therapy approved for various cancers including melanoma and non-small cell lung cancer (NSCLC), and ipilimumab, an anti-CTLA-4 therapy approved for melanoma. Additionally, drugs like nivolumab, another anti-PD-1 therapy, and atezolizumab, an anti-PD-L1 therapy, have been approved for NSCLC and other cancers. These therapies work by targeting specific pathways involved in tumor growth and immune evasion, similar to the investigational drug INCB161734 being studied for KRAS G12D mutated tumors.

What other types of research exist?

Promising novel alternatives to INCB161734 for solid tumor patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in various solid tumors including non-small cell lung cancer (NSCLC) and sarcomas. 2) Capmatinib and Tepotinib, MET inhibitors, effective in NSCLC with MET exon 14 skipping mutations. 3) Abemaciclib, a CDK4/6 inhibitor, particularly for dedifferentiated liposarcoma. 4) Nivolumab, alone or in combination with Ipilimumab, for various advanced solid tumors including mesothelioma and sarcomas.

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Targeted Therapy

INCB161734 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Disease group 2: diagnosis of CRC

Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 and 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called INCB161734 to see if it is safe for cancer patients. Researchers are checking if it can be used alone or with other treatments without causing harmful side effects.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success, be intolerant to them, or have no other treatment options available to improve their condition.

What is being tested?

The study tests the safety and effects of INCB161734 alone or combined with anticancer therapies like Cetuximab and Retifanlimab. It aims to find out how well these treatments work on various solid tumors with the KRAS G12D mutation.

What are the potential side effects?

Possible side effects from INCB161734, Cetuximab, and Retifanlimab may include reactions at the infusion site, skin issues, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, and potential organ-related inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with colorectal cancer.

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My condition is an advanced solid tumor not classified in groups 1, 2, or 3.

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I am 18 years old or older.

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My cancer has a KRAS G12D mutation and has spread.

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My cancer diagnosis was confirmed through tissue examination.

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I have been diagnosed with non-small cell lung cancer.

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I have been diagnosed with pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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 participants with Dose Limiting Toxicities (DLTs)

Number of participants with TEAEs leading to dose modification or discontinuation

Number of participants with Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Disease Control Response (DCR)

Duration of Response (DOR)

INCB161734 pharmacokinetic (PK) in Plasma

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2b: Dose Expansion combinationExperimental Treatment5 Interventions

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Group II: Part 2a: Dose Escalation combinationExperimental Treatment5 Interventions

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Group III: Part 1d: Food-EffectExperimental Treatment1 Intervention

Evaluate food effect on drug exposure as defined in the protocol.

Group IV: Part 1c: Pharmacodynamic cohortExperimental Treatment1 Intervention

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group V: Part 1b: Dose Expansion monotherapyExperimental Treatment1 Intervention

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group VI: Part 1a: Dose Escalation monotherapyExperimental Treatment1 Intervention

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mFOLFIRINOX

2013

Completed Phase 2

~90

Cetuximab

2011

Completed Phase 3

~2480

Retifanlimab

2018

Completed Phase 2

~430

0 / 7Eligibility 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

Targeted therapies and small molecule inhibitors, such as those being studied in the trial INCB161734, work by specifically targeting molecular pathways that are essential for tumor growth and survival. These treatments often inhibit proteins or enzymes that are mutated or overexpressed in cancer cells, such as kinases involved in cell signaling pathways. By blocking these critical pathways, targeted therapies can effectively halt tumor progression and induce cancer cell death while minimizing damage to normal cells. This precision makes them particularly valuable for patients with solid tumors, as they offer a more tailored and potentially less toxic treatment option compared to traditional chemotherapy.