UK Center for Clinical and Translational Science

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

Purpose

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).

Condition

Solid Tumor

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts 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 - 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

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part 1: Dose Escalation Monotherapy (Solid Tumors)		Drug: IDE397 IDE397 dosed orally
Experimental Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial)		Drug: IDE397 IDE397 dosed orally
Experimental Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial)		Drug: IDE397 IDE397 dosed orally Drug: Docetaxel Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial)		Drug: IDE397 IDE397 dosed orally Drug: Docetaxel Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (Urothelial)		Drug: IDE397 IDE397 dosed orally Drug: Sacituzumab govitecan Intravenous infusion
Experimental Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (Urothelial)		Drug: IDE397 IDE397 dosed orally Drug: Sacituzumab govitecan Intravenous infusion

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Markey Cancer Center
Lexington, Kentucky 40536

Contact:
Heather Flynn
707-521-3830
heather.flynn@uky.edu

More Details

NCT ID: NCT04794699
Status: Recruiting
Sponsor: IDEAYA Biosciences

Study Contact

IDEAYA Clinical Trials
+1 650 534 3616
IDEAYAClinicalTrials@ideayabio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.