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Trial record 1 of 1 for:    VT1021
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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 : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Vigeo Therapeutics, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 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 2020
Estimated Study Completion Date : December 2020

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




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



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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

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
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Contact: Michael Cieslewicz, PHD 617-945-0385 michael.cieslewicz@vigeotherapeutics.com
Contact: Jing Watnick, PHD, MBA 617-945-0385 jing.watnick@vigeotherapeutics.com

Locations
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United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Horizon Oncology Center Recruiting
Lafayette, Indiana, United States, 47905
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Recruiting
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
START Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Vigeo Therapeutics, Inc.
Investigators
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Study Director: Lou Vaickus, MD Medical Director
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Responsible Party: Vigeo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03364400    
Other Study ID Numbers: VT1021-01
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms