Health TrialsbyHealthPanel

Study of INCB123667 in Subjects With Advanced Solid Tumors

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

About this trial

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older at the time of the signing of the ICF.

Life expectancy greater than 12 weeks.

ECOG performance status score of 0 or 1.

Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.

Disqualifiers

History of clinically significant or uncontrolled cardiac disease.

History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.

Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.

Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INCB0123667

    Drug

    25 mg tablets

  • Palbociclib

    Drug

    Palbociclib will be administered at protocol defined dose.

  • Bevacizumab

    Drug

    Bevacizumab will be administered at protocol defined dose.

  • Olaparib

    Drug

    Olaparib will be administered at protocol defined dose.

  • Paclitaxel

    Drug

    Paclitaxel will be administered at protocol defined dose.

  • Ribociclib

    Drug

    Ribociclib will be administered at protocol defined dose.

  • Fulvestrant

    Drug

    Fulvestrant will be administered at protocol defined dose.

Treatment groups

604 Participants
are divided into 21 treatment groups

21

Treatment groups

See each treatment group below.

Group A: Phase 1a Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b: Dose Expansion Cohort Disease Group 1Experimental treatment 1 intervention
Group C: Phase 1b: Dose Expansion Cohort Disease Group 2Experimental treatment 1 intervention
Group D: Phase 1b: Dose Expansion Cohort Disease Group 3Experimental treatment 1 intervention
Group E: Phase 1b: Dose Expansion Cohort Disease Group 4Experimental treatment 1 intervention
Group F: Phase 1b: Dose Expansion Cohort Disease Group 5Experimental treatment 1 intervention
Group G: Phase 1b: Dose Expansion Cohort Disease Group 6Experimental treatment 1 intervention
Group H: Phase 2a Dose Escalation Treatment Group A (TGA)Experimental treatment 2 interventions
Group I: Phase 2a Dose Escalation Treatment Group B (TGB)Experimental treatment 3 interventions
Group J: Phase 2a Dose Escalation Treatment Group C (TGC)Experimental treatment 2 interventions
Group K: Phase 2a Dose Escalation Treatment Group D (TGD)Experimental treatment 3 interventions
Group L: Phase 2a Dose Escalation Treatment Group E (TGE)Experimental treatment 2 interventions
Group M: Phase 2a Dose Escalation Treatment Group F (TGF)Experimental treatment 2 interventions
Group N: Phase 2a Dose Escalation Treatment Group G (TGG)Experimental treatment 2 interventions
Group O: Phase 2b Dose Expansion Treatment Group H (TGH)Experimental treatment 2 interventions
Group P: Phase 2b Dose Expansion Treatment Group I (TGI)Experimental treatment 3 interventions
Group Q: Phase 2b Dose Expansion Treatment Group J (TGJ)Experimental treatment 2 interventions
Group R: Phase 2b Dose Expansion Treatment Group K (TGK)Experimental treatment 3 interventions
Group S: Phase 2b Dose Expansion Treatment Group L (TGL)Experimental treatment 2 interventions
Group T: Phase 2b Dose Expansion Treatment Group M (TGM)Experimental treatment 2 interventions
Group U: Phase 2b Dose Expansion Treatment Group N (TGN)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

Time frame
Up to Day 28
2

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Time frame
Up to 12 months
3

Number of Participants with Dose Interruptions due to TEAE

Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

Time frame
Up to 12 months
4

Number of Participants who Undergo Dose Reductions due to TEAE

Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

Time frame
Up to 12 months

Secondary outcomes

1

PK parameters: Cmax

Defines as the maximum (peak) plasma drug concentration

Time frame
Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)
2

PK parameters: tmax

Defined as the time to reach maximum (peak) plasma concentration following drug administration

Time frame
Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)
3

PK parameters: Ctau

Ctau is defined as concentration at the end of the dosing interval

Time frame
Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)
4

PK Parameters: AUC

Defined as the area under the plasma concentration-time curve

Time frame
Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

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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