NSCLC Adenocarcinoma study: IDE892 vs IDE397
Official title A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07277413
What this study is testing
What is IDE892?
an investigational oral medicine being studied as a potential treatment for advanced or metastatic NSCLC adenocarcinoma with MTAP deletions. is designed to inhibit the enzyme protein arginine methyltransferase 5 (PRMT5), which may affect tumor growth in MTAP‑deleted cancers.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the drug IDE892 is safe and how well it works when used alone or with other treatments.
- Who it's for
- The study is looking for adults with advanced solid tumors, such as lung, stomach, or bladder cancer, that have a specific genetic change called MTAP deletion.
- What's involved
- Participants will receive IDE892 either by itself or combined with other drugs, and researchers will monitor their health and blood levels of the medicine.
- Time commitment
- The source text does not specify the total duration of the study or the required visit schedule.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Are willing and able to provide blood/tumor tissue samples for biomarker testing.
- 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)
You likely can't join if
- 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...
- Have a history of severe infections within 4 weeks prior to the start of study treatment
See the full eligibility 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...
- 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 swallow and retain orally administered study drug/IMP.
- Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- Male and female: willing to use contraception
- 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 with a positive test at screening
- Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
- Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP
- 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...
- 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...
- 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 Amethionine adenosyltransferase 2A (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 Eligibility Criteria for Participants with NSCLC (All Parts)
- 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...
- Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.
- 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...
- Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors
- Must have progressed following at least 1 prior line of therapy
- Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease
The study team makes the final eligibility decision.
Where it is enrolling
- Goodyear, Arizona, United States
- Phoenix, Arizona, United States
- Duarte, California, United States
- Santa Rosa, California, United States
- Washington D.C., District of Columbia, United States
- Coral Springs, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Zion, Illinois, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- East Brunswick, New Jersey, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Irving, Texas, United States
- West Valley City, Utah, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Goodyear, Arizona, United States; Phoenix, Arizona, United States; Duarte, California, United States; Santa Rosa, California, United States; Washington D.C., District of Columbia, United States; Coral Springs, Florida, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.