To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
570
INCA33890 will be administered at protocol defined dose.
Bevacizumab will be administered at protocol defined dose.
FOLFIRI will be administered at protocol defined dose.
Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Treatment Emerging Adverse Events (TEAEs)
Time frame: Up to 2 years
TEAEs leading to dose modification or discontinuation
Time frame: Up to 2 years
Objective response Rate
Time frame: 2 years
Disease Control Rate
Time frame: 2 years
Duration of Response
Time frame: 2 years
Pharmacokinetics Parameter : Cmax of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : Tmax of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : Cmin of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : AUC(0-t) of INCA33890
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FOLFOX will be administered at protocol defined dose.
Cetuximab will be administered at protocol defined dose.
ADG126 will be administered at protocol defined dose.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGCancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGNyu Langone Health - Long Island Hospital
Mineola, New York, United States
RECRUITINGLaura and Isaac Perlmutter Cancer Center
New York, New York, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGLifespan Cancer Research Institute
Providence, Rhode Island, United States
RECRUITINGUniversity of Texas Md Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 29 more locations
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : AUC 0-∞ of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : CL of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : Vz of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : t1/2 of INCA33890
Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up