Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07765836
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pancreatic Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vilastobart (XTX101) — DRUG
    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).
  • Retifanlimab — DRUG
    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.

Study Details

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).

Key Dates

First listed
Aug 14, 2026
Start date
Jan 31, 2027
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vilastobart + Retifanlimab
    This arm involves screening, study treatment with the study drugs, study visits, and follow-up visits for up to 3 years from time of joining study. Participants will receive up to 4 doses of Vilastobart, and Retifanlimab every three weeks until disease progression, intolerable side effects, or for a total of one year. Premedication for all vilastobart doses is required. For participants who experience disease progression on retifanlimab monotherapy or after completion of therapy on trial may be considered for re-induction with vilastobart and retifanlimab. Treatment beyond disease progression will be permitted for first instance of progressive disease by RECIST only if patients remain clinically stable from their disease and ongoing treatment is considered appropriate by patient, treating physician, and Sponsor Investigator.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 1 year from baseline. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Harshabad Singh, MBBS MD
[email protected]
617-724-4000
Harshabad Singh, MBBS MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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