Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Condition(s) studied
Investigational drug(s) / intervention(s)
IDE397: IDE397 dosed orally
Sacituzumab govitecan: Intravenous infusion
Study summary
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).
Eligibility
Primary outcome measure(s)
- Dose-limiting Toxicities (DLTs) of IDE397 — 21 days following the first dose of IDE397
Incidence of DLTs of IDE397 will be determined - Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan — 21 - 28 days following the first dose of IDE397
Incidence of DLTs of IDE397 in a combination setting will be determined - Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 — Approximately 2 years
MTD and RP2D of IDE397 will be determined - Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan — Approximately 2 years
MTD and RP2D of IDE397 in a combination setting will be determined - To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms — Approximately 2 years
Objective Response Rate (ORR) and Duration of Response (DoR)
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | |
| Rockefeller Cancer Institute | Little Rock | Arkansas | |
| City of Hope | Duarte | California | |
| Orlando Health Cancer Institute | Orlando | Florida | |
| Indiana University Health Hospital | Indianapolis | Indiana | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Columbia University Medical Center - Herbert Irving Pavilion | New York | New York | |
| Weill Cornell Medical College | New York | New York | |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| LifeSpan - Brown University | Providence | Rhode Island | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| MD Anderson | Houston | Texas | |
| Next Oncology | San Antonio | Texas | |
| Swedish Cancer Institute | Seattle | Washington | |
| The Kinghorn Cancer Centre, St Vincent's Health Network Sydney | Darlinghurst | New South Wales | |
| Southern Oncology Clinical Research Unit | Bedford Park | South Australia | |
| Institut Bergonie | Bordeaux | Bordeaux Cedex | |
| Institut Claudius Regaud - IUCT-Oncopole | Toulouse | Cedex 9 | |
| Hôpital Timone | Marseille | Marseille | |
| Centre Georges Francois LeClerc | Dijon | France | |
| Centre Eugène Marquis | Rennes | France | |
| Gustave Roussy | Villejuif | France | |
| Universitaetsklinikum Hamburg-Eppendorf (UKE) | Hamburg | Germany | |
| National Cancer Center | Goyang-si | Gyeonggi-do | |
| CHA University - Bundang Medical Center | Seongnam-si | Gyeonggi-do | |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | |
| Sevrance Hospital | Seoul | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Seoul National University Hospital | Seoul | South Korea | |
| Hospital Universitario 12 de Octubre (H12O) | Madrid | Spain | |
| START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC) | Madrid | Spain | |
| NEXT Madrid, Universitary Hospital QuironSAlud | Madrid | Spain | |
| Instituto Valenciano de Oncología (IVO) | Valencia | Spain | |
| National Cheng Kung University Hospital | Tainan | Tainan | |
| National Taiwan University Hospital | Taipei | Taipei |
On this site
📄 Trodelvy (sacituzumab govitecan) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04794699 on ClinicalTrials.gov ↗ ← All trials in South Korea