To hear about similar clinical trials, please enter your email below
Trial Title:
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
NCT ID:
NCT06414460
Condition:
Locally Advanced/Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Methionine adenosyltransferase 2A (MAT2A)
homozygous MTAP deletion
MAT2A inhibitor
ISM3412
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ISM3412
Description:
ISM3412 will be administered orally once daily.
Arm group label:
Part 1 Dose Escalation
Arm group label:
Part 2 Dose Selection Optimization
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.
Criteria for eligibility:
Criteria:
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. 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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2025
Completion date:
March 31, 2029
Lead sponsor:
Agency:
InSilico Medicine Hong Kong Limited
Agency class:
Industry
Source:
InSilico Medicine Hong Kong Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06414460
