A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors

Vigeo Therapeutics, Inc.12 sites in 1 country116 target enrollmentNovember 28, 2017

ConditionsSolid Tumor

InterventionsVT1021

DrugsVT1021

Overview

Phase: Phase 1
Intervention: VT1021
Conditions: Solid Tumor
Sponsor: Vigeo Therapeutics, Inc.
Enrollment: 116
Locations: 12
Primary Endpoint: Identify recommended phase 2 dose by measuring incidence of dose limiting toxicities at increasing dose levels. Determine the safety and tolerability of VT1021 in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36 high cohort.
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an an open-label Phase I trial of VT1021 in patients with advanced solid tumors. Patients must have recurrent or advanced cancer (i.e., solid tumors) for which standard therapy offers no curative potential.

Detailed Description

This is an open-label Phase I study of VT1021 in patients with advanced solid tumors. The study will include a Dose Escalation Phase and a Dose Expansion Phase. Upon determination of the Recommended Phase 2 Dose in the Dose Escalation Phase, the Dose Expansion Phase will be opened. The Dose Expansion Phase will include cohorts in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36-high patients in order to confirm the tolerability of VT1021 against specific tumor types.

Registry

clinicaltrials.gov

Start Date

November 28, 2017

End Date

June 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Vigeo Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Dose Escalation Phase:
•Patients must be refractory to, or intolerant of, existing therapies known to provide clinical benefit for their condition (i.e., cancer diagnosis)
•Dose Expansion Phase:
•Patients with confirmed diagnosis of unresectable epithelial ovarian, fallopian tube, or primary peritoneal cancer must have received ≤ 3 prior lines of therapy in a platinum resistant setting. BRCA mutant patients are excluded unless they have failed previous line with a PARP inhibitor
•Pancreatic:
•Patients with confirmed diagnosis of pancreatic cancer must have received ≤2 prior lines of therapy
•Triple Negative Breast Cancer:
•Patients with confirmed diagnosis of metastatic TNBC must have received ≤ 3 prior lines of therapy for metastatic disease
•Glioblastoma:
•Patients with confirmed relapsed or refractory glioblastoma must have received ≤2 prior lines of systemic therapy

Exclusion Criteria

•Diagnosis of another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, superficial bladder cancer, or endometrial cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment)
•History of a major surgical procedure or a significant traumatic injury within 14 days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study
•Treatment with investigational therapy(ies) within 5 half-lives of the investigational therapy prior to the first scheduled day of dosing with VT1021, or 4 weeks if the half-life of the investigational agent is not known
•Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association (NYHA) class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B, hepatitis C or HIV, or other significant co-morbid conditions that, in the opinion of the Investigator, would impair study participation or cooperation
•Pregnancy or lactation
•Evidence of symptomatic brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible, assuming the patient has adequately recovered from treatment
•Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy
•Requirement to palliative radiotherapy to lesions that are defined as target lesions by RECIST criteria at the time of study entry

Arms & Interventions

VT1021

Escalating doses of VT1021 to determine RP2D

Intervention: VT1021

Outcomes

Primary Outcomes

Identify recommended phase 2 dose by measuring incidence of dose limiting toxicities at increasing dose levels. Determine the safety and tolerability of VT1021 in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36 high cohort.

Time Frame: 2 doses weekly for 4 week cycle

Increasing dose levels until RP2D determined.

Secondary Outcomes

To determine overall response rate by iRECIST(Through study completion, an average of 1 year)
To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 5.0 in subjects with advanced solid tumors.(2 doses weekly for 4 week cycle)
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameters of the terminal elimination of half-life(2 cycles of 2 doses weekly for 4 week cycle)
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Cmax(2 cycles of 2 doses weekly for 4 week cycle)
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Tmax(2 cycles of 2 doses weekly for 4 week cycle)
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameters of clearance, volume of distribution at steady state (Vdss)(2 cycles of 2 doses weekly for 4 week cycle)
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-t(2 cycles of 2 doses weekly for 4 week cycle)
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-∞(2 cycles of 2 doses weekly for 4 week cycle)
To determine preliminary evidence of efficacy of VT1021 monotherapy(Through study completion, an average of 1 year)