History of Changes for Study: NCT03364400

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors

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Study Record Versions

Version	Submitted Date	Changes
1	November 30, 2017	None (earliest Version on record)
2	April 4, 2018	Contacts/Locations and Study Status
3	September 10, 2018	Contacts/Locations and Study Status
4	November 28, 2018	Contacts/Locations and Study Status
5	June 10, 2019	Contacts/Locations and Study Status
6	March 9, 2020	Outcome Measures, Contacts/Locations, Study Status, Study Description, IPDSharing, Eligibility, Arms and Interventions and Study Design
7	April 20, 2020	Contacts/Locations and Study Status
8	August 3, 2020	Contacts/Locations and Study Status
9	March 8, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design
10	April 25, 2022	Study Status
11	October 21, 2022	Study Status
12	May 12, 2023	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	VT1021-01
Brief Title:	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
Secondary IDs:

Study Status


Record Verification:	November 2017
Overall Status:	Recruiting
Study Start:	November 28, 2017
Primary Completion:	September 2019 [Anticipated]
Study Completion:	December 2019 [Anticipated]

First Submitted:	November 15, 2017
First Submitted that Met QC Criteria:	November 30, 2017
First Posted:	December 6, 2017 [Actual]

Last Update Submitted that Met QC Criteria:	November 30, 2017
Last Update Posted:	December 6, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	Vigeo Therapeutics, Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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 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.

Conditions


Conditions:	Solid Tumor
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Sequential Assignment
Number of Arms:	1
Masking:	None (Open Label)
Enrollment:	70 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: VT1021 Escalating Doses of VT1021	Drug: VT1021 Peptide

Outcome Measures


Primary Outcome Measures:
1.	Identified recommended phase 2 dose by measuring incidence of dose limiting toxicities (DLTs) (Grade 2 or higher Adverse Events as measured by CTCAE v4.03) at increasing dose levels. Dose escalation only. [ Time Frame: 2 doses weekly for 4 week cycle (28 days) ] Only toxicities occurring during Cycle 1 of study therapy will be considered as DLTs and utilized to inform dose escalation decisions. As safety data become available for patients remaining on-study after Cycle 1, these data will be taken into consideration by the Sponsor when making decisions about continued dose-escalation and defining a RP2D.
Secondary Outcome Measures:
1.	To characterize the adverse event profile of VT1021 monotherapy as measured by CTCAE v 4.03 in subjects with advanced solid tumors. [ Time Frame: 2 doses weekly for 4 week cycle (28 days) ] • To characterize the type, frequency and severity of the adverse events of VT1021 monotherapy determined by CTCAE v 4.03
2.	Analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Cmax [ Time Frame: 2 cycles of2 doses weekly for 4 weeks (56 days) ] The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
3.	Analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Tmax [ Time Frame: 2 cycles of 2 doses weekly for 4 weeks (56 days) ] The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
4.	Analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-t [ Time Frame: 2 cycles of 2 doses weekly for 4 weeks (56 days) ] The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
5.	Analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-∞ [ Time Frame: 2 cycles of 2 doses weekly for 4 weeks (56 days) ] The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
6.	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) [ Time Frame: 2 cycles of 2 doses weekly for 4 weeks (56 days) ] The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).
7.	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 half-life [ Time Frame: 2 cycles of 2 doses weekly for 4 weeks (56 days) ] The pharmacokinetics of VT1021 will be measured on Cycle 1 day 1 (pre-dose, 0,2,4,6, and 24 hours post dose; cycle 1 day 4 pre-dose, 0,2,4,6 and 24 hours post dose; cycle 1 day 11, 15, 18, 22, and 25, pre-dose, 0 and 2 hrs post-dose; Cycle 2 day 50 pre-dose, 0,2,4,6 and 24 hours post-dose).

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Patients must be refractory to, or intolerant of, existing therapies known to provide clinical benefit for their condition (i.e., cancer diagnosis). Patient has evaluable disease by RECIST v1.1 (Appendix 3). Patient has a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale Patient is at least 21 days removed from therapeutic radiation or chemotherapy prior to the first scheduled day of dosing with VT1021. Patient has adequate organ function Exclusion Criteria: 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.

Contacts/Locations


Central Contact Person:	Kathleen Roberge, MSc, MSN Telephone: 617-945-0385 Email: kathleen.roberge@vigeotherapeutics.com
Central Contact Backup:	Michael Cieslewicz, PHD Telephone: 6179450385 Email: michael.cieslewicz@vigeotherapeutics.com
Study Officials:	Richard Messmann, MD, MHS Study Director Senior Medical Director
	Anthony Tolcher, MD Principal Investigator START San Antonio
	Wael Harb, MD Principal Investigator Horizon Oncology
Locations:	United States, Texas
	START [Recruiting] San Antonio, Texas, United States, 78229 Contact:Contact: Isabel Jimenez 210-593-5265 mailto:isabel.jimenez@startsa.com Contact:Principal Investigator: Anthony Tolcher, MD

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: