The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.
The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the homologous recombination (HR) pathway and in combination with pembrolizumab in participants with advanced/recurrent endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Oral Medication
Intravenous Infusion
HonorHealth Research Institute
Phoenix, Arizona, United States
WITHDRAWNThe Angeles Clinic
Los Angeles, California, United States
RECRUITINGHoag Memorial Hospital
Newport Beach, California, United States
ACTIVE_NOT_RECRUITINGCalifornia Pacific Medical Center
San Francisco, California, United States
Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE
* Incidence of Dose Limiting Toxicities * Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Time frame: Approximately 2 years
Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE
* Incidence of treatment-emergent AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
Time frame: Approximately 4 years
Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab
Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
Time frame: Approximately 4 years
Part 2 (Dose Expansion) Assess the risk/benefit at an IDE161 monotherapy dose and exposure alternative to the initial expansion dose; as well as an IDE161 dose in combination with a fixed dose of pembrolizumab and exposure alternative to the initial
Descriptively compare the totality of emerging data (efficacy, safety, PK, PD) between the initial expansion dose cohort and dose optimization cohort
Time frame: Approximately 4 years
To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Single-dose PK parameters of IDE161
Time frame: Approximately 4 years
To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Multiple-dose PK parameters of IDE161
Time frame: Approximately 4 years
To characterize the single dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.
Single-dose PK parameters of IDE161
Time frame: Approximately 4 years
To characterize the multiple dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.
Multiple-dose PK parameters of IDE161
Time frame: Approximately 4 years
To characterize the single dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.
Single-dose PK parameters of IDE161
Time frame: Approximately 4 years
To characterize the multiple dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.
Multiple-dose PK parameters of IDE161
Time frame: Approximately 4 years
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Sarah Cannon Research Institute
Denver, Colorado, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGOrlando Health
Orlando, Florida, United States
WITHDRAWNEmory University
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGOSF St Francis Medical Center
Peoria, Illinois, United States
WITHDRAWNIndiana University
Indianapolis, Indiana, United States
COMPLETED...and 17 more locations