Trials / Completed
CompletedNCT02646852
A Phase I Study of PLX038 in Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- ProLynx LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I, open-label, two-arm, dose escalation study of PLX038 intravenous infusion administered to patients with refractory or relapsed solid tumors. This study will explore two different dosing schedules: Arm 1, once every 3 week (q3w), and Arm 2, once weekly for 2 consecutive weeks of a 4-week cycle.
Detailed description
PLX038 is an investigational drug product that has demonstrated reasonable antitumor activity in preclinical colorectal, gastric and lung tumor models in animals. This is a first in human trial to determine the maximum, safest dose of PLX038 IV that can be administered to patients either once every 3 weeks or once every 2 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PLX038 |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2023-02-01
- Completion
- 2023-07-01
- First posted
- 2016-01-06
- Last updated
- 2023-07-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02646852. Inclusion in this directory is not an endorsement.