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โ† Trials
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Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllInSilico Medicine Hong Kong Limited
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In plain words

What the trial is, and whether it could suit you

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female participants with age โ‰ฅ18 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) โ‰ค1. 5. Life expectancy of โ‰ฅ12 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 โ‰ค1 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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What it tests

  • ISM3412
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Where

10 sites
Sarah Cannon Research Institute at HealthONE
Denver, United States
Smilow Cancer Hospital at Yale New Haven Breast Center
New Haven, United States
Community Cancer Center North
Indianapolis, United States
SCRI Oncology Partners
Nashville, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University People's Hospital
Beijing, China
Sun Yat-sen university cancer center
Guangzhou, China

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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