BridgeMD
New treatment option for Locally Advanced/Metastatic Solid Tumors
Official title Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06414460
What this study is testing
What is ISM3412?
ISM3412 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced/metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1.
- Life expectancy of ≥12 weeks as judged by the investigator.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Indianapolis, Indiana, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; New Haven, Connecticut, United States; Indianapolis, Indiana, United States; Nashville, Tennessee, United States; Houston, Texas, United States; Beijing, Beijing Municipality, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.