Announcements and Reminders

11-Mar-2026 Study Update

Clarification on Data Entry Rollover. Please ensure you are not entering a transition date into EDC until the first monthly auto injector visit occurs.

10-Mar-2026 Study Update

Clarification on Malnutrition Collection and Supply Details. Adverse Events of Special Monitoring.

04-Mar-2026 Study Update

VK2735-301 IRT Updates. Site FAQ/Discussion Guide. Daylight Savings. Advarra ICF Changes.

27-Feb-2026 Study Update

PI/CRC Call Follow-Up. Autoinjector Injection Video. Pharmacy Manual. Advarra ICF Changes.

23-Feb-2026 Study Update

Auto Injector Roll Out & Supply Details. Drug Holiday and Restarting IP. MRL Reminders. Investigator's Brochure. Upcoming PI/CRC Teleconferences (PAV5.0 Training and Important Study Updates)

17-Feb-2026 Study Update

Initial Auto Injector & Supply Shipments BMI Dose Modifications Under PA5. MRL Reminders. Upcoming PI/CRC Teleconferences (PAV5.0 Training and Important Study Updates).

10-Feb-2026 Study Update

Upcoming PI/RC Teleconferences (PAV5.0 Training and Important Study Updates). IP Storage. BMI Down Titration. Visit Windows.

03-Feb-2026 Study Update

Upcoming PI/CRC Teleconferences. IP Storage Concerns Survey. Visit Guidance. Concomitant Medication. BMI Down Titration. IRT Quick Reference Guide V2.0. PCS Travel and Reimbursement Policy V3.

26-Jan-2026 Study Update

IP Autoinjector Storage Concerns Survey. IRT Reminder for Resuming IP After 2 Consecutive Missed Doses.

16-Jan-2026 Study Update

VANQUISH 301 Protocol Amendment 4.0 Materials. Laboratory Manual v4.0, dated 19-Dec-2025. Retention Reminders. Autoinjector Transition.

12-Jan-2026 Study Update

VANQUISH 301/302 Dose Dispensing Worksheet. Temperature Excursion Reporting Reminders. MRL Reminder. Autoinjector.

06-Jan-2026 Study Update

Study Reminders. Sharps Containers and Coolers Shipments. End of Study Stipend Clarification. PI/CRC Call Follow-up.

27-Feb-2026 Study Update

February 27, 2026

Thank you for all your efforts on this study so far!

PI/CRC Call Follow-up

Previously distributed via email you will find the slides from the PI/CRC call this week. Thank you again for your attendance and participation. We will distribute the minutes with Q&A soon.

Autoinjector Injection Video

Viking Vanquish 1 V1.0 on Vimeo

Study Reminders

Pharmacy Manual

Please see the V5.0 of the Pharmacy Manual along with its supporting logs previously sent via email.

Part B Autoinjector Subject Accountability Log

Part B Autoinjector Master Accountability Log

AI Compliant Intake Form

Temperature Excursion Form V3.0

Advarra ICF Changes

We have seen and are aware of multiple versions of the consent form being released in a rapid period due to errors made by Advarra during IRB finalization of the updated consent corresponding with PAV5.0. Medpace is working to obtain additional guidance from Advarra on reconsenting requirements and additional details are forthcoming. Thank you for your patience and understanding.