A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP
Servier Bio-Innovation LLC
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Pati…
Interventions
- DrugS095035
S095035 will be taken orally every day in 28-day cycles.
- DrugTNG462
TNG462 will be taken orally every day in 28-day cycles.
Locations (35)
- University of California Los AngelesLos Angeles, California
- University of California, San Francisco (Ucsf) School of MedicineSan Francisco, California
- Lake Mary Cancer Center - Florida Cancer Specialists & Research InstituteLake Mary, Florida
- Community Health NetworkIndianapolis, Indiana
- Dana Farber Cancer InstitueBoston, Massachusetts
- Duke University School of MedicineDurham, North Carolina