MedTrace Logo

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

NCT03900442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-02

No results posted yet for this study

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

Interventions

DRUG

PTX-100

Doses of 500 to 2000 mg/m2 will be administered.

Sponsors & Collaborators

  • Prescient Therapeutics, Ltd.

    lead INDUSTRY

Principal Investigators

  • Terrence Chew, MD · Prescient Therapeutics, Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-07-31
Completion
2025-08-08
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900442 on ClinicalTrials.gov