Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion (NCT04794699) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
United States, Australia, France169 participantsStarted 2021-04-14
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-limiting Toxicities (DLTs) of IDE397
Timeframe: 21 days following the first dose of IDE397
2
Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
Timeframe: 21 - 28 days following the first dose of IDE397
3
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Timeframe: Approximately 2 years
4
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
Timeframe: Approximately 2 years
5
To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms