Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL). Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC).
Part 2 cohort expansion is now enrolling Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) patients who may have one or more of these genetic alterations, BRCA 1 mutation, BRCA 2 mutation, MYC amplification/ overexpression, Homologous Recombination Deficient (HRD) positive.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Oral capsules
O'Neal Comprehensive Cancer Center at the University of Alabama
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
MemorialCare - Orange Coast Medical Center
Fountain Valley, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Precision NextGen Oncology
Los Angeles, California, United States
Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Community Health Network Community Cancer Center South
Indianapolis, Indiana, United States
Community Health Network Community Cancer Center North
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
...and 14 more locations
Part 1 and Part 2: Incidence of Adverse Events (AEs)
Type, incidence, severity, causality and outcome of adverse events (AEs), including serious AEs and AEs at Grade 3 or above, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Number of Participants with Dose Limiting Toxicity (DLT) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Maximally Tolerated Dose (MTD) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Recommended Phase 2 Dose (RP2D) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Part 1: Maximal Plasma Concentration (Cmax) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1: Time to Maximal Plasma Concentration (Tmax) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1: Area Under The Plasma Concentration x Time Curve From Hour 0 to The Last Measurable Time Point (AUC0-last) of KB-0742
Time frame: Cycle 1 Day 1 through Cycle 6 Day 1, where a cycle is up to 28 days
Part 1 and Part 2: Progression Free Survival (PFS)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Disease Control Rate
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Duration of Disease Control
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Overall Response Rate (ORR)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 1 and Part 2: Duration of Response (DOR)
Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
Part 2: Maximal Plasma Concentration (Cmax) of KB-0742
Time frame: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Part 2: Time to Maximal Plasma Concentration (Tmax) of KB-0742
Time frame: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
Part 2: Trough Concentration (Ctrough) of KB-0742
Time frame: Cycle 1 Day 1 and Cycle 1 Day 12, where a cycle is up to 28 days
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