NSCLC AdenocarcinomaPhase 1NCT07277413
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
A Phase 1 study testing IDE892 and IDE397 in people with NSCLC Adenocarcinoma and Gastroesophageal Cancer (GC), run by IDEAYA Biosciences at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma
- What is being tested?
- IDE892 and IDE397
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 23 sitesUnited States
- Study dates
- 4 Mar 2026to 30 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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; 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 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 developed intolerance) in the metastatic setting
- 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 least 1 prior line containing appropriate targeted therapy.
- Eligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)
- 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
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
BRCR Global-Coral Springs
Coral Springs, Florida, 33065
Alina Quintana, 561-447-0614, alinaq@brcrglobal.com
- Recruiting
City of Hope Cancer Center-Duarte
Duarte, California, 91010
Abhishek Tripathi, M.D., 626-218-9200, atripathi@coh.org
- Recruiting
START Astera, LLC
East Brunswick, New Jersey, 08816
Hope Team Distribution List, hopeteam@startresearch.com
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
- Recruiting
START Dallas Fort Worth
Fort Worth, Texas, 76104
Kasie Newton, 682-350-3010, kasie.newton@startresearch.com
- Recruiting
City of Hope Cancer Center-Phoenix
Goodyear, Arizona, 85338
Amit Kulkarni, MD, 612-624-9604, amkulkarni@coh.org
- Recruiting
MD Anderson
Houston, Texas, 77030
Jordi Rodon Ahnert, MD, PhD, 713-563-1930, JRodon@mdanderson.org
- Recruiting
NEXT Oncology Houston
Houston, Texas, 77054
Emma Morales, 832-384-7912, emorales@nextoncology.com
- Recruiting
NEXT Oncology Dallas
Irving, Texas, 75039
Mofopefoluwa Akinwale, 972-893-8800, fakinwale@nextoncology.com
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Conor D. O'Donnell, M.B., B.Ch., B.A.O., 855-776-0015
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Alydia Miller, 615-927-2212, alydia.miller@scri.com
Sarah Cannon Institute, 844-482-4812, asksarah@sarahcannon.com
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Nurse Navigation Team: Contact for All Patient Referrals, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Lindsey Becker, Primary Study Coordinator, 402-691-5255, lbecker@nebraskacancer.com
- Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
Elizabeth Gilmore, 904-380-2410, Elizabeth.Griffith@Scri.com
- Recruiting
Sidney Kimmel Comprehensive Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
askphase1@jefferson.edu, 215-586-0199
askphase1@jefferson.edu
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mitesh J. Borad, M.D., 855-776-0015
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kaushal Parikh, M.B.B.S., 855-776-0015
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
Ian Anderson, MD, 707-521-3830, ian.anderson@providence.org
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
Siddhartha Devarakonda, MD, 206-386-2424, siddhartha.devarakonda@swedish.org
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Mauricio Ribeiro, MD, 813-745-3242, mauricio.ribeiro@moffitt.org
Anisa Gonzalez, 813-745-3874, anisa.gonzalez@moffitt.org
- Recruiting
Johns Hopkins Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Solmaz Sahebjam, MD, 202-669-6500, ssahebj1@jh.edu
Mahlet Atnafu, 202-669-6500, SibleyOncResReferral@live.johnshopkins.edu
- Recruiting
START Mountain Region, LLC
West Valley City, Utah, 84119
Marie Asay, Director, Nursing, 801-907-4770, marie.asay@startresearch.com
- Recruiting
City of Hope Cancer Center-Chicago
Zion, Illinois, 60099
Evan Pisick, M.D., 415-353-9674, episick@coh.org
About this study
Official title: A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors
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.
Read the detailed description
The purpose of this study is to evaluate safety, efficacy, and PK of IDE892 as monotherapy and combination therapy in adult participants with MTAP-deleted tumors who have progressed after standard therapy and represent a high unmet need. In the current stage, the combination will be focused on IDE892 with IDE397, an oral inhibitor of methionine adenosyltransferase 2A (MAT2A), to fully exploit the vulnerabilities associated with methylthioadenosine (MTA) accumulation in MTAP-deleted tumors while maintaining a substantial therapeutic index. The mechanistic rationale for this study is discussed in the following sections.
- Conditions
- NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC)
- Being tested
- IDE892, IDE397
- Keywords
- MTAP deletion, MTAP loss, MTAP-deficient tumors, homozygous MTAP loss, IDE892, IDE397, MAT2A inhibitor, PRMT5, advanced solid tumors, metastatic cancer, recurrent cancer, dose escalation, dose expansion, phase 1 clinical trial, ctDNA
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Mesothelioma, Mesothelioma, Malignant, Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDE892Drug
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.
IDE397Drug
IDE397 is an oral MAT2A inhibitor that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions. In this study, IDE397 will be evaluated in combination with IDE892 (Parts 3 and 4) in participants with MTAP-deleted advanced solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: IDE892 Monotherapy Dose Escalation (MTAP-deleted advanced solid tumors) | Experimental | Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892. Dose levels will be escalated sequentially using a Bayesian Optimal Interval (BOIN) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK and pharmacodynamics (PD) and preliminary antitumor activity will also be assessed. Receives: Drug: IDE892 |
| Part 2: IDE892 Monotherapy Dose Expansion (MTAP-Deleted NSCLC) | Experimental | Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892. One or more dose levels at or below the maximum tolerated dose from Part 1 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity. Receives: Drug: IDE892 |
| Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors) | Experimental | Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892 in combination with IDE397. Dose levels will be escalated using a modified toxicity probability interval (mTPI) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK, PD, and preliminary antitumor activity will also be assessed. Receives: Drug: IDE892; Drug: IDE397 |
| Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC) | Experimental | Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892 in combination with IDE397. One or more dose levels at or below the maximum tolerated dose from Part 3 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity. Receives: Drug: IDE892; Drug: IDE397 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3)
Incidence of DLTs of IDE892 will be determined in Parts 1 and 3
Measured: 21 days following the first dose of IDE892 (each cycle is 21 days)
Incidence of AEs and SAEs (Parts 1, 2, 3, and 4)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (graded based on Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) will be determined in Parts 1, 2, 3, and 4.
Measured: 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)
Objective response rate (ORR: best objective response of complete response [CR] + partial response [PR]) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator
Measured: Approximately 2 years
Secondary outcomes (15)
Overall response rate (ORR) and duration of response (DOR) per RECIST version 1.1 (Parts 1 and 3)
ORR and DOR per RECIST version 1.1 as assessed by the Investigator
Measured: Approximately 2 years
Disease control rate (DCR) and duration of stable disease per RECIST version 1.1 (Parts 1, 2, 3, and 4)
Disease control rate (disease control rate [DCR]: CR + PR + stable disease [SD]) and duration of SD per RECIST version 1.1 as assessed by the Investigator
Measured: Approximately 2 years
Maximum Observed Plasma Concentration (Cmax) (Parts 1, 2, 3, and 4)
Cmax is the highest observed plasma concentration of the study drug following administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Time to Maximum Observed Concentration (Tmax)
Time to Maximum Observed Concentration (Tmax) after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast)
AUClast reflects total drug exposure from dosing until the last measurable concentration after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Time of Last Quantifiable Concentration (Tlast)
Tlast is the time at which the final measurable drug concentration is observed after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf)
AUCinf represents total drug exposure extrapolated to infinite time after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Terminal Elimination Half-Life (t½)
t½ is the time required for the plasma concentration of the drug to decrease by half during the terminal elimination phase after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Cmax,ss is the maximum observed plasma concentration after achieving steady state after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 15 (each cycle is 21 days)
Time to Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss is the time from dosing to Cmax at steady state after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 15 (each cycle is 21 days)
Trough Plasma Concentration at Steady State (Ctrough)
Ctrough is the concentration obtained immediately prior to the next scheduled dose at steady state after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau)
AUCtau represents drug exposure over one full dosing interval at steady state after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 15 (each cycle is 21 days)
Apparent Clearance (CL/F)
CL/F is the apparent clearance of the drug after extravascular dosing after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Apparent Volume of Distribution (Vz/F)
Vz/F is the apparent volume of distribution following extravascular dosing after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Accumulation Ratio (Rac)
Rac is calculated as the ratio of AUC or Cmax at steady state compared with first dose, reflecting drug accumulation after administration of IDE892 as a single agent or in combination with IDE397
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start4 Mar 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by IDEAYA BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDEAYA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Chan, MD, Study director, IDEAYA Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277413
- Sponsor's protocol ID
- IDE892-001
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07277413
- Acronym / sponsor ID
- IDE892-001
- Conditions
- NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC)
- Keywords
- MTAP deletion, MTAP loss, MTAP-deficient tumors, homozygous MTAP loss, IDE892, IDE397, MAT2A inhibitor, PRMT5
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- IDEAYA BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to evaluate safety, efficacy, and PK of IDE892 as monotherapy and combination therapy in adult participants with MTAP-deleted tumors who have progressed after standard therapy and represent a high unmet need. In the current stage, the combination will be focused on IDE892 with IDE397, an oral inhibitor of methionine adenosyltransferase 2A (MAT2A), to fully exploit the vulnerabilities associated with methylthioadenosine (MTA) accumulation in MTAP-deleted tumors while maintaining a substantial therapeutic index. The mechanistic rationale for this study is discussed in the following sections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: IDE892 Monotherapy Dose Escalation (MTAP-deleted advanced solid tumors) | Experimental | Drug: IDE892Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892. Dose levels will be escalated sequentially using a Bayesian Optimal Interval (BOIN) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK and pharmacodynamics (PD) and preliminary antitumor activity will also be assessed. |
| Part 2: IDE892 Monotherapy Dose Expansion (MTAP-Deleted NSCLC) | Experimental | Drug: IDE892Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892. One or more dose levels at or below the maximum tolerated dose from Part 1 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity. |
| Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors) | Experimental | Drug: IDE892, Drug: IDE397Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892 in combination with IDE397. Dose levels will be escalated using a modified toxicity probability interval (mTPI) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK, PD, and preliminary antitumor activity will also be assessed. |
| Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC) | Experimental | Drug: IDE892, Drug: IDE397Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892 in combination with IDE397. One or more dose levels at or below the maximum tolerated dose from Part 3 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDE892IDE892 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. | Drug | Part 1: IDE892 Monotherapy Dose Escalation (MTAP-deleted advanced solid tumors), Part 2: IDE892 Monotherapy Dose Expansion (MTAP-Deleted NSCLC), Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors), Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC) |
| IDE397IDE397 is an oral MAT2A inhibitor that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions. In this study, IDE397 will be evaluated in combination with IDE892 (Parts 3 and 4) in participants with MTAP-deleted advanced solid tumors. | Drug | Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors), Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC) |
Primary outcome
Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3)
Time frame: 21 days following the first dose of IDE892 (each cycle is 21 days)
Incidence of DLTs of IDE892 will be determined in Parts 1 and 3
Incidence of AEs and SAEs (Parts 1, 2, 3, and 4)
Time frame: From first dose until 28 days after last dose (each cycle is 21 days)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (graded based on Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) will be determined in Parts 1, 2, 3, and 4.
Objective response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts 2 and 4)
Time frame: Approximately 2 years
Objective response rate (ORR: best objective response of complete response [CR] + partial response [PR]) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator
15 secondary outcomes
Overall response rate (ORR) and duration of response (DOR) per RECIST version 1.1 (Parts 1 and 3)
Time frame: Approximately 2 years
Disease control rate (DCR) and duration of stable disease per RECIST version 1.1 (Parts 1, 2, 3, and 4)
Time frame: Approximately 2 years
Maximum Observed Plasma Concentration (Cmax) (Parts 1, 2, 3, and 4)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Time to Maximum Observed Concentration (Tmax)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Time of Last Quantifiable Concentration (Tlast)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Terminal Elimination Half-Life (t½)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Time frame: Cycle 1 Day 15 (each cycle is 21 days)
Time to Maximum Concentration at Steady State (Tmax,ss)
Time frame: Cycle 1 Day 15 (each cycle is 21 days)
Trough Plasma Concentration at Steady State (Ctrough)
Time frame: Cycle 1 Day 15 (each cycle is 21 days)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau)
Time frame: Cycle 1 Day 15 (each cycle is 21 days)
Apparent Clearance (CL/F)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Apparent Volume of Distribution (Vz/F)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Accumulation Ratio (Rac)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward Chan, MD study director
IDEAYA Biosciences
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDE892 and IDE397 in people with NSCLC Adenocarcinoma and Gastroesophageal Cancer (GC), run by IDEAYA Biosciences at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IDEAYA Clinical Trials (+1 855 433 2246, IDEAYAClinicalTrials@ideayabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3) (time frame: 21 days following the first dose of IDE892 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.