Clinical Trials /

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

NCT03364400

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Fallopian Tube Carcinoma
  • Glioblastoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: VT1021-01
  • NCT ID: NCT03364400

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
VT1021VT1021

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
VT1021ExperimentalEscalating doses of VT1021 to determine RP2D
  • VT1021

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Increasing dose levels until RP2D determined.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:To characterize the type, frequency and severity of the adverse events of VT1021 monotherapy determined by CTCAE v 5.0
Measure: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
Safety Issue:
Description:The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
Measure: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
Safety Issue:
Description:The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
Measure: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
Safety Issue:
Description:The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
Measure: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
Safety Issue:
Description:The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
Measure: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
Safety Issue:
Description:The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
Measure: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
Safety Issue:
Description:The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2
Measure:To determine preliminary evidence of efficacy of VT1021 monotherapy
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Using objective response rate based on RECIST v1.1 and RANO
Measure:To determine preliminary evidence of efficacy of VT1021 monotherapy
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Using disease control rate
Measure:To determine preliminary evidence of efficacy of VT1021 monotherapy
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Using progression free survival based on RECIST v1.1 and RANO
Measure:To determine overall response rate by iRECIST
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Using radiographic imaging assessment of disease

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Vigeo Therapeutics, Inc.

Last Updated

March 9, 2020