Clinical trial · Interventional
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas
NCT04089449CI-TRIAL-00065329completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Recurrent Glioma | Glioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRT811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRT811
- description
- PRT811 will be administered orally
- interventionNames
- Drug: PRT811
Primary outcomes (3)
- measure
- To describe dose limiting toxicities (DLT) of PRT811
- timeFrame
- Baseline through Day 21
- description
- Dose limiting toxicities will be evaluated through the first cycle
- measure
- To determine the maximally tolerated dose (MTD)
- timeFrame
- Baseline through approximately 2 years
- description
- The MTD will be established for further investigation in participants with solid tumors and gliomas
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies * Subjects must have recovered from the effects of any prior investigational system therapies * For subjects with recurrent high-grade glioma or GBM, must have biopsy proven evidence (WHO Grade III or IV) and received external bean fractionated radiotherapy and at least 2 cycles of adjuvant temozolomide chemotherapy. Mutant Glioma must comply with biomarker defined enrollment criterias. * For biomarker-selected solid tumors: must meet enrollment criteria * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 * Adequate organ function (bone marrow, hepatic, renal, cardiovascular) * Female subjects of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial Exclusion Criteria: * Untreated concurrent malignancies or malignancies that have been in complete remission for less than one year * Treatment with strong inhibitors of CYP3A4 for which there are no therapeutic substitutions * Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption * HIV positive; known active hepatitis B or C * Known hypersensitivity to any of the components of PRT811
References
Publications (1)
- DERIVEDBarry A, Samuel SF, Hosni I, Moursi A, Feugere L, Sennett CJ, Deepak S, Achawal S, Rajaraman C, Iles A, Wollenberg Valero KC, Scott IS, Green V, Stead LF, Greenman J, Wade MA, Beltran-Alvarez P. Investigating the effects of arginine methylation inhibitors on microdissected brain tumour biopsies maintained in a miniaturised perfusion system. Lab Chip. 2023 May 30;23(11):2664-2682. doi: 10.1039/d3lc00204g. PMID 37191188