A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

New Cancer Drug IDE892 Trial for Advanced Solid Tumors

NCT: NCT07277413 · Status: RECRUITING · Phase: Phase 1 · Sponsor: IDEAYA Biosciences · Started: 2026-03-04 · Est. Completion: 2028-04-30

Plain English Summary

A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors is a Phase 1 clinical trial sponsored by IDEAYA Biosciences studying NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC), Bladder Cancer, Mesothelioma, Pleural Mesothelioma, Peritoneal Mesothelioma. This trial tests a new drug called IDE892, alone or with another drug (IDE397), to see if it's safe and effective. It's for adults with advanced solid tumors that have a specific genetic change called MTAP deletion. Participation involves taking study drugs, regular check-ups, and providing blood and tumor samples. Alternative treatments may include chemotherapy, targeted therapy, or immunotherapy, depending on the cancer type and prior treatments. The trial aims to enroll 260 participants.

Official 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

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with specific types of advanced solid tumors (lung, esophageal, stomach, bladder, or mesothelioma) that have an MTAP deletion. Patients must have tumors that can be measured and a good general health status (ECOG 0-1) with a life expectancy over 3 months. Individuals with brain metastases, recent other cancers, significant heart problems, uncontrolled effusions, or certain infections may not be eligible. Previous treatments for lung cancer must include platinum chemotherapy and a PD-1/PD-L1 inhibitor. This trial is studying NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC), Bladder Cancer, Mesothelioma, Pleural Mesothelioma, Peritoneal Mesothelioma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the drug is by tracking side effects and how well it shrinks tumors or controls their growth. The specific primary outcome measures are: Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3) (21 days following the first dose of IDE892 (each cycle is 21 days)); Incidence of AEs and SAEs (Parts 1, 2, 3, and 4) (From first dose until 28 days after last dose (each cycle is 21 days)); Objective response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts 2 and 4) (Approximately 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a gap in treatment for advanced solid tumors with MTAP deletion, a genetic change that can make some cancers harder to treat. This research targets NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC), Bladder Cancer, Mesothelioma, Pleural Mesothelioma, Peritoneal Mesothelioma, where improved treatment options are needed.

Investor Insight

This Phase 1 trial of IDE892, targeting a specific genetic alteration in solid tumors, signals a focused approach in a competitive oncology market with potential for novel therapies. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of IDE892 and if it's appropriate for your cancer. Be prepared for regular clinic visits for drug administration, blood draws, scans, and monitoring of side effects. You will need to provide tumor tissue and blood samples for genetic testing and to monitor how the drug works. This trial is currently recruiting participants. The trial is being conducted at 10 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Are ≥ 18 years of age 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 \[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\], NSCLC \[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\] and 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 \> 3 months
* Have adequate bone marrow and organ function
* Able to retain administered study drug/IMP.
* Male and female: willing to use contraception

Exclusion Criteria:

* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids
* Have a known primary central nervous system (CNS) malignancy
* Have had other malignancies within 2 years prior to the first dose, with some exceptions
* Impaired cardiac function or clinically significant cardiac diseases
* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter
* Have a history of severe infections within 4 weeks prior to the start of study treatment
* Hypertension (e.g., \> 150/100 mmHg) that cannot be controlled by medications despite optimal medical therapy
* Other acute or chronic medical or psychiatric condition
* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening
* Known or suspected viral hepatitis
* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
* Have received chemotherapy within 3 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks
* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP
* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein
* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4/5, Strong inhibitors of P-gp and/or BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP
* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study
* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892
* Previous treatment with a MAT2A inhibitor and/or Protein arginine N-methyltransferase (PRMT) inhibitor
* Major surgery within 4 weeks before study entry
* Prior irradiation to \> 25% of the bone marrow
* Known or suspected hypersensitivity to IDE892

Disease-Specific Eligibility Criteria NSCLC

* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1/PD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting
* Treatment with no more than 3 prior lines, including no more than 2 prior lines of chemotherapy.
* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.

Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal) and Gastroesophageal Cancers

* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, or gastroesophageal cancer
* Must ha

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07277413?

NCT07277413 is a Phase 1 INTERVENTIONAL study titled "A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors." It is currently recruiting and is sponsored by IDEAYA Biosciences. The trial targets enrollment of 260 participants.

What conditions does NCT07277413 study?

This trial investigates treatments for NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC), Bladder Cancer, Mesothelioma, Pleural Mesothelioma, Peritoneal Mesothelioma. The primary condition under study is NSCLC Adenocarcinoma.

What treatments are being tested in NCT07277413?

The interventions being studied include: IDE892 (DRUG), IDE397 (DRUG). IDE892 is an inhibitor of the Protein arginine methyltransferase 5 (PRMT5) that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions.

What does Phase 1 mean for NCT07277413?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT07277413?

This trial is currently "Recruiting." It started on 2026-03-04. The estimated completion date is 2028-04-30.

Who is sponsoring NCT07277413?

NCT07277413 is sponsored by IDEAYA Biosciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07277413?

The trial aims to enroll 260 participants. The trial is currently recruiting and accepting new participants.

How is NCT07277413 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT07277413?

The primary outcome measures are: Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3) (21 days following the first dose of IDE892 (each cycle is 21 days)); Incidence of AEs and SAEs (Parts 1, 2, 3, and 4) (From first dose until 28 days after last dose (each cycle is 21 days)); Objective response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts 2 and 4) (Approximately 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07277413 being conducted?

This trial is being conducted at 10 sites, including Orlando, Florida; Omaha, Nebraska; New York, New York; Philadelphia, Pennsylvania and 6 more sites (United States).

Where can I find official information about NCT07277413?

The official record for NCT07277413 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07277413. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07277413 testing in simple terms?

This trial tests a new drug called IDE892, alone or with another drug (IDE397), to see if it's safe and effective. It's for adults with advanced solid tumors that have a specific genetic change called MTAP deletion.

Why is this trial significant?

This trial addresses a gap in treatment for advanced solid tumors with MTAP deletion, a genetic change that can make some cancers harder to treat.

What are the potential risks of participating in NCT07277413?

Common side effects may include fatigue, nausea, vomiting, and changes in blood counts. More serious risks can include severe allergic reactions, heart problems, or effects on organ function. Specific risks related to combination therapy will also be monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07277413?

Ask your doctor about the specific risks and benefits of IDE892 and if it's appropriate for your cancer. Be prepared for regular clinic visits for drug administration, blood draws, scans, and monitoring of side effects. You will need to provide tumor tissue and blood samples for genetic testing and to monitor how the drug works. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07277413 signal from an investment perspective?

This Phase 1 trial of IDE892, targeting a specific genetic alteration in solid tumors, signals a focused approach in a competitive oncology market with potential for novel therapies. This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves taking study drugs, regular check-ups, and providing blood and tumor samples. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More NSCLC Adenocarcinoma Trials

View all NSCLC Adenocarcinoma clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.