A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors
Summary
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).
Arms & interventions
- DrugINCB0123667
25 mg tablets
- DrugPalbociclib
Palbociclib will be administered at protocol defined dose.
- DrugBevacizumab
Bevacizumab will be administered at protocol defined dose.
- DrugOlaparib
Olaparib will be administered at protocol defined dose.
- DrugPaclitaxel
Paclitaxel will be administered at protocol defined dose.
- DrugRibociclib
Ribociclib will be administered at protocol defined dose.
- DrugFulvestrant
Fulvestrant will be administered at protocol defined dose.
Outcome measures
Primary
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
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
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
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
Number of Participants Discontinue study due to TEAE
TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 12 months
Secondary
PK parameters: Cmax
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)
PK parameters: tmax
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)
PK parameters: Ctau
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)
PK Parameters: AUC
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)
PK Parameters: CL/F
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)
PK Parameters: Vz/F
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)
PK Parameters: t1/2
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)
Objective Response Rate (ORR)
Time frame: Up to 12 months
Disease Control
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 12 months
Eligibility criteria
Study locations (19)
City of Hope Medical Center
Duarte, California, 91010
City of Hope-Lennar Foundation Cancer Center
Irvine, California, 92618
Valkyrie Clinical Trials
Los Angeles, California, 90067
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Yale Cancer Center
New Haven, Connecticut, 06510
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140
Emory University
Atlanta, Georgia, 30322
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
New York Presbyterian/Weill Cornell
New York, New York, 10065
Ny Cancer and Blood Specialists
Shirley, New York, 11967
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina, 28078
Cleveland Clinic
Cleveland, Ohio, 44195
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15213
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Tennessee Oncology
Nashville, Tennessee, 37203
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas, 76104
Virginia Cancer Institute
Fairfax, Virginia, 22031
University of Wisconsin
Madison, Wisconsin, 53792