Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: VT1021

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Horizon Oncology Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Beth Israel
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • START

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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:

   Ovarian:

   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

   CD36-high basket cohort:

   Patients with solid tumor cancers that have high expression of CD36 by immunohistochemistry. Patients must have received ≤ 3 prior lines of therapy for metastatic disease

2. Patient has evaluable disease by RECIST v1.1
3. Patient has a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
4. Patient is at least 21 days (12 weeks for glioblastoma patients) removed from therapeutic radiation or chemotherapy prior to the first scheduled day of dosing with VT1021
5. Patient has adequate organ function
6. Patient agrees to use acceptable methods of contraception during the study and 60 days after the last dose of VT1021

Exclusion Criteria:

1. 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)
2. 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
3. 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
4. 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
5. Pregnancy or lactation
6. 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
7. Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy
8. Requirement to palliative radiotherapy to lesions that are defined as target lesions by RECIST criteria at the time of study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VT1021; Escalating doses of VT1021 to determine RP2D	Drug: VT1021; Peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Increasing dose levels until RP2D determined.	2 doses weekly for 4 week cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 5.0 in subjects with advanced solid tumors.	To characterize the type, frequency and severity of the adverse events of VT1021 monotherapy determined by CTCAE v 5.0	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	The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2	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	The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2	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	The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2	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-∞	The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2	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 the terminal elimination of half-life	The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2	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)	The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2	2 cycles of 2 doses weekly for 4 week cycle
To determine preliminary evidence of efficacy of VT1021 monotherapy	Using objective response rate based on RECIST v1.1 and RANO	Through study completion, an average of 1 year
To determine preliminary evidence of efficacy of VT1021 monotherapy	Using disease control rate	Through study completion, an average of 1 year
To determine preliminary evidence of efficacy of VT1021 monotherapy	Using progression free survival based on RECIST v1.1 and RANO	Through study completion, an average of 1 year
To determine overall response rate by iRECIST	Using radiographic imaging assessment of disease	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Vigeo Therapeutics, Inc.
• Investigators: Study Director: Judy Chaio, MD, Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: VT1021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No