Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
NCT ID: NCT06414460
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2025-04-25
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation
Patients will receive ISM3412 once daily in sequential cohorts of increasing doses.
ISM3412
ISM3412 will be administered orally once daily.
Part 2 Dose Selection Optimization
Participants will be randomized to receive one of the two selected dose levels of ISM3412 once daily determined by Study Review Committee.
ISM3412
ISM3412 will be administered orally once daily.
Interventions
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ISM3412
ISM3412 will be administered orally once daily.
Eligibility Criteria
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Inclusion Criteria
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. Participants must provide a documentary evidence of homozygous MTAP deletion; or provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or at least 15 FFPE tumor tissue slides, or perform tumor tissue biopsies for a confirmatory genetic test indicating homozygous MTAP deletion.
5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1.
6. Life expectancy of ≥12 weeks as judged by the investigator.
7. Adequate organ function as determined by medical assessment.
8. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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InSilico Medicine Hong Kong Limited
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Smilow Cancer Hospital at Yale New Haven Breast Center
New Haven, Connecticut, United States
Community Cancer Center North
Indianapolis, Indiana, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Rebecca Griffith
Role: CONTACT
Facility Contacts
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Patricia LoRusso
Role: primary
Kai Yao
Role: primary
Other Identifiers
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ISM3412-101
Identifier Type: -
Identifier Source: org_study_id
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