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Targeted Therapy

Part 2a: Dose Escalation combination 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

Study Summary

This trial aims to find out if INCB161734 is safe and well-tolerated when used alone or in combination with other cancer treatments.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Disease Control Response (DCR)

Duration of Response (DOR)

INCB161734 pharmacokinetic (PK) in Plasma

+1 more

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

365 Previous Clinical Trials

54,973 Total Patients Enrolled

Incyte Medical MonitorStudy DirectorIncyte Corporation

23 Previous Clinical Trials

4,750 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of individuals participating in this investigation?

"A total of 322 eligible individuals who meet the specified inclusion criteria are needed to participate in this research. Patients have the opportunity to enroll from various locations, including Chris O'Brien Lifehouse in Camperdown, New South Wales and MD Anderson Cancer Center in Houston, Texas."

Answered by AI

In how many medical facilities is this examination being conducted?

"Thirteen medical facilities, including Chris Obrien Lifehouse in Camperdown, MD Anderson Cancer Center in Houston, and Peter MacCallum Cancer Centre in North Melbourne are actively recruiting patients for this clinical trial. Additionally, there are 10 other locations involved in patient recruitment as well."

Answered by AI

Is this medical study currently open for enrollment?

"Indeed, the information obtained from clinicaltrials.gov indicates that this study is currently seeking eligible participants. The trial was initially posted on January 4th, 2024 and underwent its most recent update on January 5th, 2024. A total of 322 individuals are being sought across a network of 13 designated sites."

Answered by AI

Has the FDA granted approval for Part 1b: Dose Expansion as a standalone treatment option?

"Based on our assessment at Power, the safety rating for Part 1b: Dose Expansion monotherapy is a 1. This reflects the limited data available regarding its safety and efficacy as it is currently in Phase 1 of clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

2024. "A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179160.

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