NCT03900442

Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort

Phase 1 Pharmacodynamic and Pharmacokinetic Study of the Geranylgeranyltransferase I Inhibitor PTX-100 (GGTI-2418) in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Prescient Therapeutics, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• PTCL

Interventions

Type	Name	Description
DRUG	PTX-100	Doses of 500 to 2000 mg/m2 will be administered.

Timeline

• Start date: 2019-09-01
• Primary completion: 2025-07-31
• Completion: 2025-08-08
• First posted: 2019-04-03
• Last updated: 2025-09-02

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study