Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/1/2018
Start Date:November 28, 2017
End Date:December 2019
Contact:Michael J Cieslewicz, PhD
Email:michael.cieslewicz@vigeotherapeutics.com
Phone:617-945-0385

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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.

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 dose in the Dose Escalation Phase, the Dose Expansion Phase will be opened.
The Dose Expansion Phase will include cohorts in selected indications in order to confirm the
tolerability of VT1021 against specific tumor types.

Inclusion Criteria:

1. Patients must be refractory to, or intolerant of, existing therapies known to provide
clinical benefit for their condition (i.e., cancer diagnosis).

2. Patient has evaluable disease by RECIST v1.1 (Appendix 3).

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 removed from therapeutic radiation or chemotherapy prior
to the first scheduled day of dosing with VT1021.

5. Patient has adequate organ function

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.
We found this trial at
3
sites
San Antonio, Texas 78229
Principal Investigator: Amita Patniak, MD
Phone: 210-593-5265
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San Antonio, TX
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Devalingham Mahalingam, MD
Phone: 312-926-5115
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Lafayette, Indiana 47905
Principal Investigator: Wael Harb, MD
Phone: 866-877-1077
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Lafayette, IN
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