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.

16-Jan-2026 Study Update

January 16, 2026

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

Study Reminders

VANQUISH 301 Protocol Amendment 4.0 Materials

Sites can expect Protocol Amendment 4.0 standard materials (Pocket Protocols, Inclusion/Exclusion cards, and Visit Schedules) onsite in the coming week.

Please login and sign off on your site specific ICF, if not already completed.

Laboratory Manual v4.0, dated 19-Dec-2025

Please see the Lab Manual v4.0 attached previously in an email for your reference.

‍Retention Reminders

Participant retention is critical for study success, regardless of treatment assignment. Should you have any concerns with participant retention due to adverse events or schedule of assessment based for those participants no longer on IP, please reach out to the Medpace Medical team with your CRA in copy.

Autoinjector Transition

Autoinjector distribution details will be available soon! As a forthcoming update in PAV5.0 will add scheduling flexibility with the transition to autoinjectors. Stay tuned for communication on these updates and the final protocol.