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Clinical Trials in China / NCT06414460
Recruiting Phase 1/2

Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

NCT06414460 · tracked via the Priya Life Science China tracker
Sponsor
InSilico Medicine Hong Kong Limited
Phase
Phase 1/2
Started
2025-04-25
Last updated
2026-09-01

Condition(s) studied

Locally Advanced/Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

ISM3412

ISM3412: ISM3412 will be administered orally once daily.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Sarah Cannon Research Institute at HealthONE Denver Colorado Recruiting
Smilow Cancer Hospital at Yale New Haven Breast Center New Haven Connecticut Recruiting
Community Cancer Center North Indianapolis Indiana Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Peking University People's Hospital Beijing Beijing Municipality Recruiting
Sun Yat-sen university cancer center Guangzhou Guangdong Recruiting
Jiangsu Provincial People's Hospital Nanjing Jiangsu Recruiting
Shanghai Gobroad Cancer Hospital Shanghai Shanghai Municipality Recruiting

More InSilico Medicine Hong Kong Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06414460 on ClinicalTrials.gov ↗ ← All trials in China