drugset / Trial / NCT03900442
Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, non-randomized study to evaluate the PD, PK, and safety of 500 to 2000 mg/m2 PTX-100 in patients with advanced malignancies. PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles unless toxicity is observed. Dose escalation is complete and the expansion is open and actively recruiting PTCL patients.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2025-07-31
- Completion
- 2025-08-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GGTI-2418 | Small molecule | 500 mg/m2 | Intravenous |
| Subject | GGTI-2418 | Small molecule | 2000 mg/m2 | Intravenous |