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Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03364400
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Vigeo Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date November 29, 2018
Actual Study Start Date  ICMJE November 28, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03364400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors
Official Title  ICMJE 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 dose in the Dose Escalation Phase, the Dose Expansion Phase will be opened. The Dose Expansion Phase will include cohorts in selected indications in order to confirm the tolerability of VT1021 against specific tumor types.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: VT1021
Peptide
Study Arms  ICMJE Experimental: VT1021
Escalating Doses of VT1021
Intervention: Drug: VT1021
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must be refractory to, or intolerant of, existing therapies known to provide clinical benefit for their condition (i.e., cancer diagnosis).
  2. Patient has evaluable disease by RECIST v1.1 (Appendix 3).
  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 removed from therapeutic radiation or chemotherapy prior to the first scheduled day of dosing with VT1021.
  5. Patient has adequate organ function

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael J Cieslewicz, PhD 617-945-0385 michael.cieslewicz@vigeotherapeutics.com
Contact: Jing Watnick, PhD, MBA 6179450385 jing.watnick@vigeotherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03364400
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Vigeo Therapeutics, Inc.
Study Sponsor  ICMJE Vigeo Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Berk, MD Medical Director
PRS Account Vigeo Therapeutics, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP