Clinical trial · Interventional
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
A Phase 1/2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced/Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ISM3412 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 Dose Escalation
- description
- Patients will receive ISM3412 once daily in sequential cohorts of increasing doses.
- interventionNames
- Drug: ISM3412
- type
- EXPERIMENTAL
- label
- Part 2 Dose Selection Optimization
- description
- Participants will be randomized to receive one of the two selected dose levels of ISM3412 once daily determined by Study Review Committee.
- interventionNames
- Drug: ISM3412
Primary outcomes (3)
- measure
- Incidence of dose-limiting toxicity (DLT) events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available