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Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03364400
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vigeo Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Judy Chaio, MD
Principal Investigator Affiliation Medical Director
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: VT1021

Escalating doses of VT1021 to determine RP2D

Interventions

Drug: - VT1021

Peptide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Florida Cancer Specialists, Sarasota, Florida

Status

Address

Florida Cancer Specialists

Sarasota, Florida, 34232

Northwestern Memorial Hospital, Chicago, Illinois

Status

Address

Northwestern Memorial Hospital

Chicago, Illinois, 60611

Horizon Oncology Center, Lafayette, Indiana

Status

Address

Horizon Oncology Center

Lafayette, Indiana, 47905

The Johns Hopkins Hospital, Baltimore, Maryland

Status

Address

The Johns Hopkins Hospital

Baltimore, Maryland, 21287

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Beth Israel, Boston, Massachusetts

Status

Address

Beth Israel

Boston, Massachusetts, 02215

Case Western Reserve University, Cleveland, Ohio

Status

Address

Case Western Reserve University

Cleveland, Ohio, 44106

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

University of Oklahoma, Oklahoma City, Oklahoma

Status

Address

University of Oklahoma

Oklahoma City, Oklahoma, 73104

MD Anderson Cancer Center, Houston, Texas

Status

Address

MD Anderson Cancer Center

Houston, Texas, 77030

START, San Antonio, Texas

Status

Address

START

San Antonio, Texas, 78229