S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic So… (NCT06188702) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
United States, Australia, France60 participantsStarted 2024-04-29
Plain-language summary
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Estimated life expectancy ≥3 months.
* ECOG PS 0-1
* Participants able to comply with highly effective method of birth control requirements.
* Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors other than IDHwt glioblastoma), with measurable disease as per RECIST 1.1 or RANO 2.0 criteria for participants with IDHwt glioblastoma, that have progressed after at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available. Patients in China with IDHwt glioblastoma will not be included.
* Participants with pre-existing documented MTAP homozygous gene deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.
* Phase 1 only - Participants (except IDHwt glioblastoma) willing to undergo paired fresh biopsy (pre-treatment and on-treatment) procedure. Exceptions may be made for feasibility and safety concerns. IDHwt glioblastoma must provide archival tissue from most recent surgery or biopsy.
* Adequate organ functions.
* Phase 2 only - Participants in dose expansion, except those with IDHwt glioblastoma, must provide newly collected tumor biopsies at screening. If not medically feasible archival tissue may be used, provided it was collected within 3 months before study entry and no treatment has been received since the most recent biopsy.
* Phase 2 onl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/2 trial and the primary focus is finding a safe dose and measuring side effects of S095035, what does that mean for what's currently known about whether this drug actually works against my MTAP-deleted tumor?
2This trial is no longer actively enrolling — does that mean there's no way for me to participate, or are there other similar MTAP-targeted trials I should be looking into instead?
3The trial is measuring dose-limiting toxicities and serious adverse events as primary outcomes, which suggests they're still learning about the drug's safety profile — given my overall health, how would you assess my ability to tolerate a treatment whose full side effect picture isn't yet established?
4Since S095035 is being tested both as a single agent and in combination with other drugs, which approach would apply to my situation, and what combination partner might be involved that I should understand the risks of?
5Before considering a trial targeting my MTAP deletion, is there an existing standard-of-care treatment for my specific cancer type that I should try first, or does the MTAP deletion make this experimental approach worth discussing as an earlier option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose limiting toxicities (DLTs)
Timeframe: Through cycle 1 (each cycle is 28 days)
2
Total number of adverse events (AEs)
Timeframe: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
3
Total number of serious adverse events (SAEs)
Timeframe: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
4
Objective response rate (ORR)
Timeframe: Through the end of the study (approximately 5 years)