A Phase I Study of PLX038 in Patients With Advanced Solid Tumors

NCT02646852 | Completed Phase 1

• 1 other identifier: D15-11073
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumors; Neoplasms; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events as a measure of safety and tolerability of PLX038

  Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.03). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  Continuous starting on day of first dose (Day 1) up to 30 days after last dose

Study Arms (2)

PLX038 Q3W

EXPERIMENTAL

intravenous infusion once every 3 weeks

Drug: PLX038

PLX038 QW ×2

EXPERIMENTAL

intravenous infusion once weekly for 2 consecutive weeks of a 4-week cycle

Drug: PLX038

Interventions

PLX038 DRUG

PLX038 Q3W; PLX038 QW ×2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically (or cytologically)-confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for which conventional systemic therapy is not reliably effective or no effective therapy is available.
• Aged ≥ 18 years.
• ECOG Performance Status of 0 or 1.
• Adequate clinical laboratory values defined as:
• absolute neutrophil count ≥ 1.5 × 10\^9/L
• platelets ≥ 100 × 10\^9/L
• hemoglobin ≥ 9.0 g/dL (transfusions permissible)
• plasma creatinine ≤ 1.5 × upper limit of normal (ULN) for the institution or calculated clearance ≥ 60 mL/min (Cockcroft-Gault formula)
• bilirubin ≤ 1.5 × ULN
• alanine transaminase (ALT) and aspartate transaminase (AST) \< 2.5 × ULN (\< 5 x ULN if documented hepatic metastases)
• Serum sodium, potassium, magnesium and calcium within normal limits for the institution (supplements may be given to correct values)
• Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
• Patients may have measurable or non-measurable disease as defined by RECIST 1.1.
• Signed informed consent prior to the start of any study specific procedures.
• Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.

You may not qualify if:

• Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for targeted therapies prior to this study entry.
• Have not recovered from adverse events (must be grade ≤1) due to agents administered more than 4 weeks earlier.
• Known hypersensitivity to any study drug component.
• Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
• Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
• Pregnant or lactating individuals.
• Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
• Known history of HIV, HBV or HCV infection.
• Documented or known bleeding disorder.
• Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).
• Clinically evident CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment. Patients with primary CNS malignancies are excluded.
• Patients with a significant cardiovascular disease or condition, including:
• Myocardial infarction within 6 months of study entry
• NYHA Class III or IV heart failure
• Uncontrolled dysrhythmias or poorly controlled angina.

Sponsors & Collaborators

• ProLynx LLC: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 6, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 12, 2023

Record last verified: 2019-01

Locations

US (1)