Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

NCT03364400 | Unknown Phase 1 FDA Drug

• 1 other identifier: VT1021-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 12

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (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.

  2 doses weekly for 4 week cycle

Secondary Outcomes (11)

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

  2 doses weekly for 4 week cycle

• To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Cmax

  2 cycles of 2 doses weekly for 4 week cycle

• To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Tmax

  2 cycles of 2 doses weekly for 4 week cycle

• 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

  2 cycles of 2 doses weekly for 4 week cycle

• To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-∞

  2 cycles of 2 doses weekly for 4 week cycle

Study Arms (1)

VT1021

EXPERIMENTAL

Escalating doses of VT1021 to determine RP2D

Drug: VT1021

Interventions

VT1021 DRUG

Peptide

VT1021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vigeo Therapeutics, Inc.: lead

Study Sites (12)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel

Boston, Massachusetts, 02215, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

START

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 38218979 DERIVED

Study Officials

• Judy Chaio, MD

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 6, 2017
• Study Start: November 28, 2017
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)