Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

Solid Tumor Clinical Trial

Official title:

An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794699
• Other study ID #: IDE397-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 14, 2021
• Est. completion date: March 30, 2027

Study information

• Verified date: May 2024
• Source: IDEAYA Biosciences
• Contact: IDEAYA Clinical Trials
• Phone: +1 650 534 3616
• Email: IDEAYAClinicalTrials[@]ideayabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 other anticancer agents including taxanes (docetaxel, paclitaxel), or 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
• Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
• Radiation therapy 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
• Currently receiving another investigational study drug.
• Known or suspected hypersensitivity to IDE397/excipients or components

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• IDE397
IDE397 dosed orally
• Docetaxel
Intravenous infusion
• Paclitaxel
Intravenous infusion
• Sacituzumab govitecan
Intravenous infusion

Locations

Country	Name	City	State
Australia	Southern Oncology Clinical Research Unit	Bedford Park	South Australia
Australia	The Kinghorn Cancer Centre, St Vincent's Health Network Sydney	Darlinghurst	New South Wales
France	Institut Bergonie	Bordeaux	Bordeaux Cedex
France	Hôpital Timone	Marseille
France	Centre Eugène Marquis	Rennes
France	Institut Claudius Regaud - IUCT-Oncopole	Toulouse	Cedex 9
Germany	Universitaetsklinikum Hamburg-Eppendorf (UKE)	Hamburg
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-Do
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi
Korea, Republic of	CHA University - Bundang Medical Center	Seongnam-si	Gyeonggi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Sevrance Hospital	Seoul
Spain	Vall Hebron Institute of Oncology	Barcelona
Spain	Hospital Universitario 12 de Octubre (H12O)	Madrid
Spain	NEXT Madrid, Universitary Hospital QuironSAlud	Madrid
Spain	START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)	Madrid
Spain	Instituto Valenciano de Oncología (IVO)	Valencia
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Advent Health	Celebration	Florida
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	MD Anderson	Houston	Texas
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Markey Cancer Center	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	SCRI Oncology Partners	Nashville	Tennessee
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	Orlando Health Cancer Institute	Orlando	Florida
United States	LifeSpan - Brown University	Providence	Rhode Island
United States	Next Oncology	San Antonio	Texas
United States	Providence Medical Group	Santa Rosa	California
United States	Honor Health Research Institute	Scottsdale	Arizona
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
IDEAYA Biosciences

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting Toxicities (DLTs) of IDE397	Incidence of DLTs of IDE397 will be determined	21 days following the first dose of IDE397
Primary	Dose-limiting Toxicities (DLTs) of IDE397 in combination with docetaxel or paclitaxel or sacituzumab govitecan	Incidence of DLTs of IDE397 in a combination setting will be determined	21 - 28 days following the first dose of IDE397
Primary	Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397	MTD and RP2D of IDE397 will be determined	Approximately 2 years
Primary	Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with docetaxel or paclitaxel or sacituzumab govitecan	MTD and RP2D of IDE397 in a combination setting will be determined	Approximately 2 years
Primary	To evaluate preliminary anti-tumor activity of IDE397 in combination expansion arms	Objective Response Rate (ORR) and Duration of Response (DoR)	Approximately 2 years
Secondary	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 docetaxel or paclitaxel or sacituzumab govitecan, will be determined	Approximately 2 years
Secondary	Drug interaction between IDE397 and docetaxel or paclitaxel or sacituzumab govitecan	Pharmacokinetics of docetaxel or paclitaxel or sacituzumab govitecan.	Approximately 2 years
Secondary	Pharmacodynamic effect of IDE397 as a single agent and in combination with docetaxel or paclitaxel or sacituzumab govitecan	Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined	Approximately 2 years
Secondary	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)	Approximately 2 years