Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

NCT04794699 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IDE397-001
• Study Type: interventional
• Target: 169
• Locations: 7 countries
• Sites: 37

Brief 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).

Conditions

Solid Tumor

Keywords

MAT2A; 9p21; CDKN2A; MTAP; Solid Tumors; PRMT5; SAM; Synthetic Lethality; Inhibitor; MTAP deletion; CDKN2A deletion; MAT2A Inhibitor; Advanced solid tumors; Lung Cancer; Bladder Cancer; Squamous; NSCLC; Urothelial Cancer; Non small cell; Sacituzumab govitecan; Trodelvy

Outcome Measures

Primary Outcomes (5)

• Dose-limiting Toxicities (DLTs) of IDE397

  Incidence of DLTs of IDE397 will be determined

  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

  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

  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

  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)

  Approximately 2 years

Secondary Outcomes (4)

• Plasma Pharmacokinetics of IDE397 and metabolite

  Approximately 2 years

• Drug interaction between IDE397 and sacituzumab govitecan

  Approximately 2 years

• Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan

  Approximately 2 years

• Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms

  Approximately 2 years

Study Arms (4)

Part 1: Dose Escalation Monotherapy (Solid Tumors)

EXPERIMENTAL

Drug: IDE397

Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial)

EXPERIMENTAL

Drug: IDE397

Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial)

EXPERIMENTAL

Drug: IDE397; Drug: Sacituzumab govitecan

Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)

EXPERIMENTAL

Drug: IDE397; Drug: Sacituzumab govitecan

Interventions

IDE397 DRUG

IDE397 dosed orally

Part 1: Dose Escalation Monotherapy (Solid Tumors); Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial); Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial); Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)

Sacituzumab govitecan DRUG

Intravenous infusion

Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial); Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IDEAYA Biosciences: lead

Study Sites (37)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

Rockefeller Cancer Institute

Little Rock, Arkansas, 72205, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

LifeSpan - Brown University

Providence, Rhode Island, 02906, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Next Oncology

San Antonio, Texas, 78229, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

The Kinghorn Cancer Centre, St Vincent's Health Network Sydney

Darlinghurst, New South Wales, 02010, Australia

Location

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 05042, Australia

Location

Institut Bergonie

Bordeaux, Bordeaux Cedex, 33076, France

Location

Institut Claudius Regaud - IUCT-Oncopole

Toulouse, Cedex 9, 31059, France

Location

Hôpital Timone

Marseille, Marseille, 13005, France

Location

Centre Georges Francois LeClerc

Dijon, France

Location

Centre Eugène Marquis

Rennes, 35000, France

Location

Gustave Roussy

Villejuif, France

Location

Universitaetsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

CHA University - Bundang Medical Center

Seongnam-si, Gyeonggi-do, 28644, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Sevrance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Universitario 12 de Octubre (H12O)

Madrid, 28041, Spain

Location

START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, 28050, Spain

Location

NEXT Madrid, Universitary Hospital QuironSAlud

Madrid, 28223, Spain

Location

Instituto Valenciano de Oncología (IVO)

Valencia, 46009, Spain

Location

National Cheng Kung University Hospital

Tainan, Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms; Urinary Bladder Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jasgit Sachdev, MD

  IDEAYA Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: April 14, 2021
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): February 4, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); KR (7); FR (6); DE (1); TW (2); AU (2); ES (4)