New hope for Hard-to-Treat cancers: first human trial of ISM3412 begins
NCT ID NCT06414460
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This early-phase study tests a new drug called ISM3412 in people with advanced solid tumors that have a specific genetic change (MTAP deletion). The main goals are to check the drug's safety and find the best dose. About 80 participants will take part in two stages: first to find a safe dose, then to confirm it works well enough for further testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 146 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants with age ≥18 years at the time of signing the informed consent. 2. Histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous MTAP deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists. 3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1. 5. Life expectancy of ≥12 weeks as judged by the investigator. 6. Adequate organ function as determined by medical assessment. 7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol. Exclusion Criteria: 1. Prior treated with other MAT2A inhibitors and/or PRMT inhibitors. 2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment. 3. Anti-tumor therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment. 4. Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0) 5. History of another primary tumor that has been diagnosed or required therapy within the past 3 years. 6. Previous history of, or presence of Gilbert's syndrome. 7. Previous history of myelodysplastic syndrome. 8. Prior solid organ or hematopoietic stem cell transplant. 9. Known active central nervous system (CNS) primary tumor or untreated CNS metastases. 10. Have serious cardiovascular or cerebrovascular disease as per protocol. 11. Presence of uncontrolled systemic infection as per protocol. 12. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition. Other protocol inclusion and exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, China
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Community Cancer Center North
RECRUITINGIndianapolis, Indiana, 46250-2042, United States
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Jiangsu Provincial People's Hospital
RECRUITINGNanjing, Jiangsu, China
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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, China
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute at HealthONE
RECRUITINGDenver, Colorado, 80218, United States
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Shanghai Gobroad Cancer Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Smilow Cancer Hospital at Yale New Haven Breast Center
RECRUITINGNew Haven, Connecticut, 06520-8028, United States
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Sun Yat-sen university cancer center
RECRUITINGGuangzhou, Guangdong, 510030, China
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The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030-4095, United States
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