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Clinical Trials in Germany / NCT04794699
Active, not recruiting Phase 1

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

NCT04794699 · tracked via the Priya Life Science Germany tracker
Sponsor
IDEAYA Biosciences
Phase
Phase 1
Started
2021-04-14
Last updated
2026-04-09

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

IDE397 →Sacituzumab govitecan →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant must be at least 18 years of age * Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy * Have evidence of homozygous loss of MTAP or MTAP deletion * Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns * Measurable disease * ECOG performance status \<= 1 * Adequate organ function * Able to swallow and retain orally administered study treatment * Recovery from acute effects of prior therapy * Able to comply with contraceptive/barrier requirements Exclusion Criteria: * Known symptomatic brain metastases * Known primary CNS malignancy * Current active liver or biliary disease * Impairment of gastrointestinal (GI) function * Active uncontrolled infection * Clinically significant cardiac abnormalities * Active second malignancy or history of another malignancy in the past 2 years * Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan * Systemic anti-cancer therapy, therapeutic antibody treatment, or major surgery within 4 weeks prior to study entry * Current radiation-related toxicity or radiation therapy within 2 weeks prior to study entry * Small molecule anti-cancer treatment within 2 weeks prior to study entry * Prior irradiation to \>25% of the bone marrow * Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers * Require concomitant use of proton pump inhibitor * Currently receiving another investigational study drug. * Known or suspected hypersensitivity to IDE397/excipients or components

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
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 →

More IDEAYA Biosciences trials in Germany

Neoadjuvant Darovasertib in Primary Uveal Melanoma Recruiting
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Active, not recruiting
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma Active, not recruiting

Other trials for the same condition

A Study of LY3200882 in Participants With Solid Tumors Active, not recruiting
Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool. Recruiting
Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors Recruiting
Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1/PD-L1 Therapy in Patients With Solid Tumors Active, not recruiting
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) Recruiting
Official registry record

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 Germany