A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors (NCT07277413) | Clinical Trial Compass
RecruitingPhase 1
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
United States260 participantsStarted 2026-03-04
Plain-language summary
This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.
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:
* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.
* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \[pleural or peritoneal\], gastroesophageal cancers \[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\] or UC \[including mixed urothelial-squamous histology\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).
* Are willing and able to provide blood/tumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.
* Must be willing and able to provide the blood/serum/plasma samples
* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)
* Have at least 1 measurable lesion according to RECIST version 1.1
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
* Have life expectancy \…
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.
1This trial is specifically for tumors that have lost a gene called MTAP — has my tumor been tested for this deletion, and if not, is that a test my care team would need to run before we could even discuss whether this trial might be relevant to me?
2Since this is a Phase 1 trial, the main goal seems to be figuring out a safe dose of IDE892 rather than proving it works — what does that mean for my personal risk compared to sticking with a standard treatment option for my specific cancer type?
3The trial is measuring something called dose-limiting toxicities, which suggests they're still learning what side effects IDE892 can cause at higher doses — based on what's known so far about this drug or its drug class, what kinds of side effects should I be prepared to discuss?
4I see the trial includes both a monotherapy part and combination treatment parts — if I were to discuss enrolling, would my doctor expect me to receive IDE892 alone or alongside another drug, and how would that affect the risk and monitoring involved?
5Given that this trial covers many different cancer types — including my diagnosis — is there any reason my doctor thinks a standard or approved therapy should come before exploring an experimental Phase 1 option like this one?
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
Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3)
Timeframe: 21 days following the first dose of IDE892 (each cycle is 21 days)
2
Incidence of AEs and SAEs (Parts 1, 2, 3, and 4)
Timeframe: From first dose until 28 days after last dose (each cycle is 21 days)
3
Objective response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts 2 and 4)