This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
169
IDE397 dosed orally
Intravenous infusion
Dose-limiting Toxicities (DLTs) of IDE397
Incidence of DLTs of IDE397 will be determined
Time frame: 21 days following the first dose of IDE397
Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
Incidence of DLTs of IDE397 in a combination setting will be determined
Time frame: 21 - 28 days following the first dose of IDE397
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
MTD and RP2D of IDE397 will be determined
Time frame: Approximately 2 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
MTD and RP2D of IDE397 in a combination setting will be determined
Time frame: Approximately 2 years
To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms
Objective Response Rate (ORR) and Duration of Response (DoR)
Time frame: Approximately 2 years
Plasma Pharmacokinetics of IDE397 and metabolite
Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration as a single agent and in combination with sacituzumab govitecan, will be determined
Time frame: Approximately 2 years
Drug interaction between IDE397 and sacituzumab govitecan
Pharmacokinetics of sacituzumab govitecan and relevant catabolism products
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Honor Health Research Institute
Scottsdale, Arizona, United States
Rockefeller Cancer Institute
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Indiana University Health Hospital
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
...and 27 more locations
Time frame: Approximately 2 years
Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan
Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined
Time frame: Approximately 2 years
Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms
Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Approximately 2 years