MTAP-null Non-Small-Cell Lung CancerPhase 1/2NCT05975073
A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
A Phase 1/2 study testing Anvumetostat and IDE397 in people with MTAP-null Non-Small-Cell Lung Cancer and MTAP-null Solid Tumors, run by Amgen at 27 sites in 7 countries.
Trial summary
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MTAP-null Non-Small-Cell Lung Cancer, MTAP-null Solid Tumors
- What is being tested?
- Anvumetostat and IDE397
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 1 Aug 2023to 26 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
- Presence of advanced/metastatic solid tumor not amenable to curative treatment
- Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
- Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
- Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
- Disease measurable as defined by RECIST v1.1
- Adequate organ function as defined in the protocol.
- Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
Who cannot join
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
- Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
- Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
- Prior irradiation to > 25% of the bone marrow
- Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sarah Cannon Research Institute
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91090
Duke University
Durham, North Carolina, 27710
Astera Cancer Care
East Brunswick, New Jersey, 08816
Prisma Health Upstate
Greenville, South Carolina, 29605
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana, 46250
Next Oncology
Irving, Texas, 75039
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016
Columbia University Irving Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55102
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Australia2 sites
Monash Medical Centre
Clayton, Victoria, 3168
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Spain2 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Universitario Ramon y Cajal
Madrid, 28034
Taiwan2 sites
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
About this study
Official title: A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
- Being tested
- Anvumetostat, IDE397
- Keywords
- Oncology, AMG 193, IDE397, anvumetostat
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnvumetostatDrug
Also called AMG 193
Administered PO
IDE397Drug
Administered PO
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Exploration of Anvumetostat Combined With IDE397 | Experimental | Participants will receive escalating doses of Anvumetostat and IDE397 administered orally (PO) in cycles of 21 days. Receives: Drug: Anvumetostat; Drug: IDE397 |
| Part 2: Dose Expansion of Anvumetostat Combined With IDE397 | Experimental | Anvumetostat and IDE397 will be administered PO in cycles of 21 days. Receives: Drug: Anvumetostat; Drug: IDE397 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Measured: Day 1 up to Day 21
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Measured: Day 1 up to approximately 2.5 years
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Day 1 up to approximately 2.5 years
Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Day 1 up to approximately 2.5 years
Secondary outcomes (18)
Part 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Cmax of IDE397
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Tmax of IDE397
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of Anvumetostat
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of Anvumetostat
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Single Dose of IDE397
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Multiple Doses of IDE397
Measured: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1: Overall Response per RECIST 1.1
Measured: Day 1 up to end-of-study (EOS) (approximately 2.5 years)
Parts 1 and 2: Disease Control Rate
Measured: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Time to Response (TTR)
Measured: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Response (DOR)
Measured: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Stable Disease
Measured: Day 1 up to EOT (approximately 6 months)
Parts 1 and 2: Progression-free Survival (PFS)
Measured: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Overall Survival (OS)
Measured: Day 1 up to EOS (approximately 2.5 years)
Part 2: Number of Participants Experiencing TEAEs
Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Measured: Day 1 up to approximately 2.5 years
Part 2: Number of Participants Experiencing SAEs
Measured: Day 1 up to approximately 2.5 years
Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood
Measured: Baseline (Day 1) to EOT plus 30 days (approximately 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Aug 2023
- Primary completion25 Feb 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTAP-null Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975073
- Sponsor's protocol ID
- 20220127
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors
- ClinicalTrials.gov ID
- NCT05975073
- Acronym / sponsor ID
- 20220127
- Keywords
- Oncology, AMG 193, IDE397, anvumetostat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 3 Aug 2023 (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.
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Exploration of Anvumetostat Combined With IDE397 | Experimental | Drug: Anvumetostat, Drug: IDE397Participants will receive escalating doses of Anvumetostat and IDE397 administered orally (PO) in cycles of 21 days. |
| Part 2: Dose Expansion of Anvumetostat Combined With IDE397 | Experimental | Drug: Anvumetostat, Drug: IDE397Anvumetostat and IDE397 will be administered PO in cycles of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
- Presence of advanced/metastatic solid tumor not amenable to curative treatment
- Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
- Disease measurable as defined by RECIST v1.1
- Adequate organ function as defined in the protocol.
Key exclusion criteria (7 listed)
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
- Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
- Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
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 |
|---|---|---|
| AnvumetostatAlso: AMG 193Administered PO | Drug | Part 1: Dose Exploration of Anvumetostat Combined With IDE397, Part 2: Dose Expansion of Anvumetostat Combined With IDE397 |
| IDE397Administered PO | Drug | Part 1: Dose Exploration of Anvumetostat Combined With IDE397, Part 2: Dose Expansion of Anvumetostat Combined With IDE397 |
Primary outcome
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 21
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to approximately 2.5 years
Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Day 1 up to approximately 2.5 years
Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Day 1 up to approximately 2.5 years
18 secondary outcomes
Part 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Cmax of IDE397
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Tmax of IDE397
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of Anvumetostat
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of Anvumetostat
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Single Dose of IDE397
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Multiple Doses of IDE397
Time frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1: Overall Response per RECIST 1.1
Time frame: Day 1 up to end-of-study (EOS) (approximately 2.5 years)
Parts 1 and 2: Disease Control Rate
Time frame: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Time to Response (TTR)
Time frame: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Response (DOR)
Time frame: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Stable Disease
Time frame: Day 1 up to EOT (approximately 6 months)
Parts 1 and 2: Progression-free Survival (PFS)
Time frame: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Overall Survival (OS)
Time frame: Day 1 up to EOS (approximately 2.5 years)
Part 2: Number of Participants Experiencing TEAEs
Time frame: Day 1 up to approximately 2.5 years
Part 2: Number of Participants Experiencing SAEs
Time frame: Day 1 up to approximately 2.5 years
Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood
Time frame: Baseline (Day 1) to EOT plus 30 days (approximately 7 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for MTAP-null Non-Small-Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
Advanced MTAP-null Solid Tumors
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.
MD study director
Amgen
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anvumetostat and IDE397 in people with MTAP-null Non-Small-Cell Lung Cancer and MTAP-null Solid Tumors, run by Amgen at 27 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 22 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 27 sites in United States, South Korea, Australia, Canada, Spain 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 21). The study lists 4 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 22 Apr 2026.