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NOT YET RECRUITING
NCT07765836
PHASE2

Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient pancreatic cancer (PC).

Official title: A Phase 2 Study of Fc Enhanced checKpoint bLockade With CTLA4 Antibody Vilastobart in Combination With PD-1 antibodY RetifAnlimab in BRCA or PALB2 Deficient Pancreatic Adenocarcinoma (EKLAVYA-HRD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2027-01

Completion Date

2030-12-31

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

DRUG

vilastobart (XTX101)

100mg administered once every 6 weeks (Day 1 of every 6-week cycle) by intravenous infusion (IV) over about 90-140 minutes. This will continue for up to 4 6-week cycles (4 doses).

DRUG

Retifanlimab

375 mg administered once every 3 weeks (Days 2 and 23 of every 6-week cycle) by intravenous infusion over about 30 minutes. This will continue for up to 12 months.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States