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: May 15, 2023
• Sponsor: Vigeo Therapeutics, Inc.
• Information provided by (Responsible Party): Vigeo Therapeutics, Inc.

Tracking Information

• First Submitted Date: November 15, 2017
• First Posted Date: December 6, 2017
• Last Update Posted Date: May 15, 2023
• Actual Study Start Date: November 28, 2017
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 9, 2020)

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.

Original Primary Outcome Measures (submitted: November 30, 2017)

Identified recommended phase 2 dose by measuring incidence of dose limiting toxicities (DLTs) (Grade 2 or higher Adverse Events as measured by CTCAE v4.03) at increasing dose levels. Dose escalation only. [ Time Frame: 2 doses weekly for 4 week cycle (28 days) ]

Only toxicities occurring during Cycle 1 of study therapy will be considered as DLTs and utilized to inform dose escalation decisions. As safety data become available for patients remaining on-study after Cycle 1, these data will be taken into consideration by the Sponsor when making decisions about continued dose-escalation and defining a RP2D.

Current Secondary Outcome Measures (submitted: March 9, 2020)

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• To determine preliminary evidence of efficacy of VT1021 monotherapy [ Time Frame: Through study completion, an average of 1 year ]
  Using disease control rate
• 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
• To determine overall response rate by iRECIST [ Time Frame: Through study completion, an average of 1 year ]
  Using radiographic imaging assessment of disease

Original Secondary Outcome Measures (submitted: November 30, 2017)

• To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 4.03 in subjects with advanced solid tumors. [ Time Frame: 2 doses weekly for 4 week cycle (28 days) ]
  • To characterize the type, frequency and severity of the adverse events of VT1021 monotherapy determined by CTCAE v 4.03
• 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 of2 doses weekly for 4 weeks (56 days) ]
  The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
• 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 weeks (56 days) ]
  The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
• 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 weeks (56 days) ]
  The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
• 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 weeks (56 days) ]
  The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
• 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 weeks (56 days) ]
  The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
• 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 half-life [ Time Frame: 2 cycles of 2 doses weekly for 4 weeks (56 days) ]
  The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors
• Official Title: A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor

Intervention

Drug: VT1021

Peptide

Study Arms

Experimental: VT1021

Escalating doses of VT1021 to determine RP2D

Intervention: Drug: VT1021

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 8, 2021): 116
• Original Estimated Enrollment (submitted: November 30, 2017): 70
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03364400
• Other Study ID Numbers: VT1021-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Vigeo Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vigeo Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Judy Chaio, MD; Medical Director

• PRS Account: Vigeo Therapeutics, Inc.
• Verification Date: May 2023