Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT03364400
• Recruitment Status: Active, not recruiting
• First Posted: December 6, 2017
• Last Update Posted: October 25, 2022
• Sponsor: Vigeo Therapeutics, Inc.
• Information provided by (Responsible Party): Vigeo Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Solid Tumor	Drug: VT1021	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors
• Actual Study Start Date: November 28, 2017
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: VT1021; Escalating doses of VT1021 to determine RP2D	Drug: VT1021; Peptide

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 5.0 in subjects with advanced solid tumors. [ Time Frame: 2 doses weekly for 4 week cycle ]
   To characterize the type, frequency and severity of the adverse events of VT1021 monotherapy determined by CTCAE v 5.0
2. To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Cmax [ Time Frame: 2 cycles of 2 doses weekly for 4 week cycle ]
   The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
3. To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Tmax [ Time Frame: 2 cycles of 2 doses weekly for 4 week cycle ]
   The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
4. 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 [ Time Frame: 2 cycles of 2 doses weekly for 4 week cycle ]
   The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
5. To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-∞ [ Time Frame: 2 cycles of 2 doses weekly for 4 week cycle ]
   The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
6. 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 [ Time Frame: 2 cycles of 2 doses weekly for 4 week cycle ]
   The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
7. 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) [ Time Frame: 2 cycles of 2 doses weekly for 4 week cycle ]
   The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
8. To determine preliminary evidence of efficacy of VT1021 monotherapy [ Time Frame: Through study completion, an average of 1 year ]
   Using objective response rate based on RECIST v1.1 and RANO
9. To determine preliminary evidence of efficacy of VT1021 monotherapy [ Time Frame: Through study completion, an average of 1 year ]
   Using disease control rate
10. To determine preliminary evidence of efficacy of VT1021 monotherapy [ Time Frame: Through study completion, an average of 1 year ]
    Using progression free survival based on RECIST v1.1 and RANO
11. To determine overall response rate by iRECIST [ Time Frame: Through study completion, an average of 1 year ]
    Using radiographic imaging assessment of disease

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Florida

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

United States, Indiana

Horizon Oncology Center

Lafayette, Indiana, United States, 47905

United States, Maryland

The Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Beth Israel

Boston, Massachusetts, United States, 02215

United States, Ohio

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Oklahoma

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

START

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Vigeo Therapeutics, Inc.

Investigators

• Study Director: Lou Vaickus, MD; Medical Director

More Information

• Responsible Party: Vigeo Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03364400
• Other Study ID Numbers: VT1021-01
• First Posted: December 6, 2017
• Last Update Posted: October 25, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms