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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 : December 6, 2017
Sponsor:
Information provided by (Responsible Party):

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 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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 : September 2019
Estimated Study Completion Date : December 2019
Arms and Interventions

Arm Intervention/treatment
Experimental: VT1021
Escalating Doses of VT1021
Drug: VT1021
Peptide


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).


Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364400


Contacts
Contact: Kathleen Roberge, MSc, MSN 617-945-0385 kathleen.roberge@vigeotherapeutics.com
Contact: Michael Cieslewicz, PHD 6179450385 michael.cieslewicz@vigeotherapeutics.com

Locations
United States, Texas
START Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5265    mailto:isabel.jimenez@startsa.com   
Principal Investigator: Anthony Tolcher, MD         
Sponsors and Collaborators
Vigeo Therapeutics, Inc.
Investigators
Study Director: Richard Messmann, MD, MHS Senior Medical Director
Principal Investigator: Anthony Tolcher, MD START San Antonio
Principal Investigator: Wael Harb, MD Horizon Oncology
More Information

Responsible Party: Vigeo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03364400     History of Changes
Other Study ID Numbers: VT1021-01
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

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