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Solid TumorPhase 1NCT03364400

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

A Phase 1 study testing VT1021 in people with Solid Tumor, run by Vigeo Therapeutics, Inc. at 12 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
VT1021
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
12 sitesUnited States
Study dates
28 Nov 2017to Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 18Show fewer
  • 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
  • Patient has evaluable disease by RECIST v1.1
  • Patient has a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • 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
  • Patient has adequate organ function
  • Patient agrees to use acceptable methods of contraception during the study and 60 days after the last dose of VT1021

Who cannot join

  • 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)
  • 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
  • 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
  • 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
  • Pregnancy or lactation
  • 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
  • Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy
  • Requirement to palliative radiotherapy to lesions that are defined as target lesions by RECIST criteria at the time of study entry

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel

    Boston, Massachusetts, 02215

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Horizon Oncology Center

    Lafayette, Indiana, 47905

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • START

    San Antonio, Texas, 78229

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors

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.

Read the 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.

Conditions
Solid Tumor
Being tested
VT1021

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VT1021Drug

    Peptide

Study groups in NCT03364400
Study groupRoleWhat they receive
VT1021ExperimentalEscalating doses of VT1021 to determine RP2D
Receives: Drug: VT1021

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Increasing dose levels until RP2D determined.

    Measured: 2 doses weekly for 4 week cycle

Secondary outcomes (11)

  1. To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 5.0 in subjects with advanced solid tumors.

    To characterize the type, frequency and severity of the adverse events of VT1021 monotherapy determined by CTCAE v 5.0

    Measured: 2 doses weekly for 4 week 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 Cmax

    The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2

    Measured: 2 cycles of 2 doses weekly for 4 week cycle

  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

    The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2

    Measured: 2 cycles of 2 doses weekly for 4 week cycle

  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

    The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2

    Measured: 2 cycles of 2 doses weekly for 4 week cycle

  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-∞

    The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2

    Measured: 2 cycles of 2 doses weekly for 4 week cycle

  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

    The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2

    Measured: 2 cycles of 2 doses weekly for 4 week cycle

  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)

    The pharmacokinetics of VT1021 will be measured on specified days during Cycle 1 and Cycle 2

    Measured: 2 cycles of 2 doses weekly for 4 week cycle

  8. To determine preliminary evidence of efficacy of VT1021 monotherapy

    Using objective response rate based on RECIST v1.1 and RANO

    Measured: Through study completion, an average of 1 year

  9. To determine preliminary evidence of efficacy of VT1021 monotherapy

    Using disease control rate

    Measured: Through study completion, an average of 1 year

  10. To determine preliminary evidence of efficacy of VT1021 monotherapy

    Using progression free survival based on RECIST v1.1 and RANO

    Measured: Through study completion, an average of 1 year

  11. To determine overall response rate by iRECIST

    Using radiographic imaging assessment of disease

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2017
  2. Study start28 Nov 2017
  3. Primary completionJan 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03364400
Sponsor's protocol ID
VT1021-01
Status last verified
May 2023
First submitted
15 Nov 2017
Last updated
15 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mahalingam D, Harb W, Patnaik A, Bullock A, Watnick RS, Vincent MY, Chen JJ, Wang S, Pestana H, Chao J, Mahoney J, Cieslewicz M, Watnick J. First-in-human phase I dose escalation trial of the first-in-class tumor microenvironment modulator VT1021 in advanced solid tumors. Commun Med (Lond). 2024 Jan 13;4(1):10. doi: 10.1038/s43856-024-00433-x.

    PubMed 38218979

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VT1021 in people with Solid Tumor, run by Vigeo Therapeutics, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03364400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

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