Health TrialsbyHealthPanel

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

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old.

Locally advanced or metastatic solid tumor with KRAS G12D mutation.

For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.

Cohort specific requirements aas defined in the protocol.

Disqualifiers

Prior treatment with any KRAS G12D inhibitor

Known additional invasive malignancy within 1 year of the first dose of study drug

History of organ transplant, including allogeneic stem cell transplantation

Significant, uncontrolled medical condition

Trial design

Design model

Sequential

Treatments tested in this trial

  • INCB161734

    Drug

    INCB161734 will be administered at protocol defined dose.

  • Cetuximab

    Drug

    Cetuximab will be administered at protocol defined dose.

  • Retifanlimab

    Drug

    Retifanlimab will be administered at protocol defined dose.

  • GEMNabP

    Drug

    GEMNabP will be administered at protocol defined dose.

  • mFOLFIRINOX

    Drug

    mFOLFIRINOX will be administered at protocol defined dose.

  • FOLFOX

    Drug

    FOLFOX will be administered at protocol defined dose.

  • FOLFIRI

    Drug

    FOLFIRI will be administered at protocol defined dose.

  • INCA33890

    Drug

    INCA33890 will be administered at protocol defined dose.

Treatment groups

710 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part 1a: Dose Escalation monotherapyExperimental treatment 1 intervention
Group B: Part 1b: Dose Expansion monotherapyExperimental treatment 1 intervention
Group C: Part 1c: Pharmacodynamic cohortExperimental treatment 1 intervention
Group D: Part 2a: Dose Escalation combinationExperimental treatment 8 interventions
Group E: Part 2b: Dose Expansion combinationExperimental treatment 8 interventions
Group F: Part 1d: Food-EffectExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Dose Limiting Toxicities (DLTs)

Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

Time frame
Up to 28 days
2

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

Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.

Time frame
Up to 2 years and 90 days
3

Number of participants with TEAEs leading to dose modification or discontinuation

Number of participants with TEAEs leading to dose modification or discontinuation.

Time frame
Up to 2 years and 90 days

Secondary outcomes

1

INCB161734 pharmacokinetic (PK) in Plasma

INCB161734 concentration in plasma.

Time frame
Up to approximately 90 days
2

Objective Response Rate (ORR)

Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Time frame
Up to 2 years
3

Disease Control Response (DCR)

Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Time frame
Up to 2 years
4

Duration of Response (DOR)

Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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