Solid TumorPhase 1NCT04794699
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
A Phase 1 study testing IDE397 and Sacituzumab govitecan in people with Solid Tumor, run by IDEAYA Biosciences at 37 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IDE397 and Sacituzumab govitecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 14 Apr 2021to 4 Feb 2027
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 strong CYP3A4/5 inhibitors or inducers
- Require concomitant use of proton pump inhibitor
- Currently receiving another investigational study drug.
- Known or suspected hypersensitivity to IDE397/excipients or components
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States15 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
City of Hope
Duarte, California, 91010
MD Anderson
Houston, Texas, 77030
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Orlando Health Cancer Institute
Orlando, Florida, 32806
LifeSpan - Brown University
Providence, Rhode Island, 02906
Next Oncology
San Antonio, Texas, 78229
Honor Health Research Institute
Scottsdale, Arizona, 85258
Swedish Cancer Institute
Seattle, Washington, 98104
South Korea7 sites
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
CHA University - Bundang Medical Center
Seongnam-si, Gyeonggi-do, 28644
Sevrance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
France6 sites
Institut Bergonie
Bordeaux, Bordeaux Cedex, 33076
Centre Georges Francois LeClerc
Dijon
Hôpital Timone
Marseille, Marseille, 13005
Centre Eugène Marquis
Rennes, 35000
Institut Claudius Regaud - IUCT-Oncopole
Toulouse, Cedex 9, 31059
Gustave Roussy
Villejuif
Spain4 sites
Hospital Universitario 12 de Octubre (H12O)
Madrid, 28041
START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, 28050
NEXT Madrid, Universitary Hospital QuironSAlud
Madrid, 28223
Instituto Valenciano de Oncología (IVO)
Valencia, 46009
Australia2 sites
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 05042
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
Darlinghurst, New South Wales, 02010
Taiwan2 sites
National Cheng Kung University Hospital
Tainan, Tainan, 704
National Taiwan University Hospital
Taipei, Taipei, 100
About this study
Official title: An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors
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).
- Conditions
- Solid Tumor
- Being tested
- IDE397, Sacituzumab govitecan
- Keywords
- MAT2A, 9p21, CDKN2A, MTAP, Solid Tumors, PRMT5, SAM, Synthetic Lethality, Inhibitor, MTAP deletion, CDKN2A deletion, MAT2A Inhibitor, Advanced solid tumors, Lung Cancer, Bladder Cancer, Squamous, NSCLC, Urothelial Cancer, Non small cell, Sacituzumab govitecan
- Medical subject headings
- Lung Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDE397Drug
IDE397 dosed orally
Sacituzumab govitecanDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation Monotherapy (Solid Tumors) | Experimental | Not described Receives: Drug: IDE397 |
| Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial) | Experimental | Not described Receives: Drug: IDE397 |
| Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial) | Experimental | Not described Receives: Drug: IDE397; Drug: Sacituzumab govitecan |
| Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial) | Experimental | Not described Receives: Drug: IDE397; Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicities (DLTs) of IDE397
Incidence of DLTs of IDE397 will be determined
Measured: 21 days following the first dose of IDE397
Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
Incidence of DLTs of IDE397 in a combination setting will be determined
Measured: 21 - 28 days following the first dose of IDE397
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
MTD and RP2D of IDE397 will be determined
Measured: Approximately 2 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
MTD and RP2D of IDE397 in a combination setting will be determined
Measured: Approximately 2 years
To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms
Objective Response Rate (ORR) and Duration of Response (DoR)
Measured: Approximately 2 years
Secondary outcomes (4)
Plasma Pharmacokinetics of IDE397 and metabolite
Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration as a single agent and in combination with sacituzumab govitecan, will be determined
Measured: Approximately 2 years
Drug interaction between IDE397 and sacituzumab govitecan
Pharmacokinetics of sacituzumab govitecan and relevant catabolism products
Measured: Approximately 2 years
Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan
Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined
Measured: Approximately 2 years
Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms
Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start14 Apr 2021
- Primary completion7 Jan 2027 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDEAYA Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jasgit Sachdev, MD, Study director, IDEAYA Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794699
- Sponsor's protocol ID
- IDE397-001
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04794699
- Acronym / sponsor ID
- IDE397-001
- Conditions
- Solid Tumor
- Keywords
- MAT2A, 9p21, CDKN2A, MTAP, Solid Tumors, PRMT5, SAM, Synthetic Lethality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 169 participants (actual)
- Lead sponsor
- IDEAYA BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 12 Mar 2021 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation Monotherapy (Solid Tumors) | Experimental | Drug: IDE397 |
| Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial) | Experimental | Drug: IDE397 |
| Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial) | Experimental | Drug: IDE397, Drug: Sacituzumab govitecan |
| Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial) | Experimental | Drug: IDE397, Drug: Sacituzumab govitecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- Known symptomatic brain metastases
- Known primary CNS malignancy
- Current active liver or biliary disease
- Impairment of gastrointestinal (GI) function
- Active uncontrolled infection
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 |
|---|---|---|
| IDE397IDE397 dosed orally | Drug | Part 1: Dose Escalation Monotherapy (Solid Tumors), Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial), Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial), Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial) |
| Sacituzumab govitecanIntravenous infusion | Drug | Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial), Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial) |
Primary outcome
Dose-limiting Toxicities (DLTs) of IDE397
Time frame: 21 days following the first dose of IDE397
Incidence of DLTs of IDE397 will be determined
Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
Time frame: 21 - 28 days following the first dose of IDE397
Incidence of DLTs of IDE397 in a combination setting will be determined
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Time frame: Approximately 2 years
MTD and RP2D of IDE397 will be determined
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
Time frame: Approximately 2 years
MTD and RP2D of IDE397 in a combination setting will be determined
To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms
Time frame: Approximately 2 years
Objective Response Rate (ORR) and Duration of Response (DoR)
4 secondary outcomes
Plasma Pharmacokinetics of IDE397 and metabolite
Time frame: Approximately 2 years
Drug interaction between IDE397 and sacituzumab govitecan
Time frame: Approximately 2 years
Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan
Time frame: Approximately 2 years
Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms
Time frame: Approximately 2 years
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 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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. This study is not recruiting at the moment.
Jasgit Sachdev, MD study director
IDEAYA Biosciences
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDE397 and Sacituzumab govitecan in people with Solid Tumor, run by IDEAYA Biosciences at 37 sites in 7 countries.
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 10 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, South Korea, France, Spain, Australia and 2 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities (DLTs) of IDE397 (time frame: 21 days following the first dose of IDE397). The study lists 5 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 9 Apr 2026.