Recruiting NCT06414460
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ISM3412.
- Who it may be relevant to
- Registry conditions: Locally Advanced/Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug ISM3412
ISM3412 will be administered orally once daily.
Primary outcome measures
- Incidence of dose-limiting toxicity (DLT) events [Time frame: 31 days]
- Incidence and severity of adverse events (AEs) [Time frame: Approximately 30 months]
- Recommended phase 2 dose (RP2D) [Time frame: Approximately 30 months]
Secondary outcome measures (7)
- Maximum observed concentration (Cmax) [Time frame: Approximately 30 months]
- Time of maximum observed concentration (Tmax) [Time frame: Approximately 30 months]
- Area under the concentration-time curve (AUC) [Time frame: Approximately 30 months]
- Terminal half-life (t1/2) [Time frame: Approximately 30 months]
- Objective response rate (ORR) [Time frame: Approximately 30 months]
- Best objective response (BOR) [Time frame: Approximately 30 months]
- Duration of response (DoR) [Time frame: Approximately 30 months]
Eligibility criteria
Inclusion criteria
- Male or female participants with age ≥18 years at the time of signing the informed consent.
- 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.
- 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.
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1.
- Life expectancy of ≥12 weeks as judged by the investigator.
- Adequate organ function as determined by medical assessment.
- Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
Exclusion criteria
- Prior treated with other MAT2A inhibitors and/or PRMT inhibitors.
- Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- 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.
- Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0)
- History of another primary tumor that has been diagnosed or required therapy within the past 3 years.
- Previous history of, or presence of Gilbert's syndrome.
- Previous history of myelodysplastic syndrome.
- Prior solid organ or hematopoietic stem cell transplant.
- Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
- Have serious cardiovascular or cerebrovascular disease as per protocol.
- Presence of uncontrolled systemic infection as per protocol.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Sarah Cannon Research Institute at HealthONE — Denver
- Smilow Cancer Hospital at Yale New Haven Breast Center — New Haven
- Community Cancer Center North — Indianapolis
- SCRI Oncology Partners — Nashville
- The University of Texas MD Anderson Cancer Center — Houston
China · 5 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Peking University People's Hospital — Beijing
- Sun Yat-sen university cancer center — Guangzhou
- Jiangsu Provincial People's Hospital — Nanjing
- Shanghai Gobroad Cancer Hospital — Shanghai
Identifiers
NCT: NCT06414460 · ISM3412-101