A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients with Advanced Solid Tumors

NOT ENROLLING
Protocol # :
18-609
Conditions
Solid Tumor
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Liu, Joyce, F
Site Investigator
Bullock, Andrea, J.
Juric, Dejan
Site Research Nurses
Baylies, Rosemarie
Bowes, Brittany, N.
Caramella, Anne
Carey, Margaret, M.
Chau, Johny, E.
Cifrino, Meghan
DeGonge, Danielle
Donohoe, Aisling
Fontana, Brittney
Gotthardt, Susan, Jean
Hedglin, Jennifer
Hindenach, Sarah
Hogan, Sarah
Hurley-Whalen, Christin
Keis, Rylee
Lafrankie, Debra
Morrissey, Stephanie, C.
Nicolazzo, Karicaty
Pagan, Shelby, E.
Powers, Allison
Rowan, Jennifer, M.

Trial 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.

Eligibility Requirements

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

18-609