Clinical trial NCT03364400: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Vigeo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
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.
timeFrame: 2 doses weekly for 4 week cycle
Secondary outcomes:
measure: To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 5.0 in subjects with advanced solid tumors.
timeFrame: 2 doses weekly for 4 week cycle
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
timeFrame: 2 cycles of 2 doses weekly for 4 week cycle
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
timeFrame: 2 cycles of 2 doses weekly for 4 week cycle
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
timeFrame: 2 cycles of 2 doses weekly for 4 week cycle
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-∞
timeFrame: 2 cycles of 2 doses weekly for 4 week cycle
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
timeFrame: 2 cycles of 2 doses weekly for 4 week cycle
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)
timeFrame: 2 cycles of 2 doses weekly for 4 week cycle
measure: To determine preliminary evidence of efficacy of VT1021 monotherapy
timeFrame: Through study completion, an average of 1 year
measure: To determine preliminary evidence of efficacy of VT1021 monotherapy
timeFrame: Through study completion, an average of 1 year
measure: To determine preliminary evidence of efficacy of VT1021 monotherapy
timeFrame: Through study completion, an average of 1 year
measure: To determine overall response rate by iRECIST
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Lafayette
country: United States
facility: Horizon Oncology Center
state: Indiana
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel
state: Massachusetts
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: START
state: Texas
Study officials:
affiliation: Medical Director
name: Judy Chaio, MD
role: STUDY_DIRECTOR
References: