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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 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

5Treatment groups
Experimental Treatment
Group I: Part 2b: Dose Expansion combinationExperimental Treatment3 Interventions
INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
Group II: Part 2a: Dose Escalation combinationExperimental Treatment3 Interventions
INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
Group III: Part 1c: Pharmacodynamic cohortExperimental Treatment1 Intervention
INCB161734 at the protocol-defined dose strength based on cohort assignment.
Group IV: Part 1b: Dose Expansion monotherapyExperimental Treatment1 Intervention
INCB161734 at the protocol-defined dose strength based on cohort assignment.
Group V: 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
Cetuximab
2011
Completed Phase 3
~2480
Retifanlimab
2018
Completed Phase 2
~320

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.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
387 Previous Clinical Trials
63,290 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
11,731 Total Patients Enrolled
~215 spots leftby Jan 2027