Recruiting
Phase 1
Phase 2

AGEN2373, Balstilimab, GVAX

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06782932

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AGEN2373

Balstilimab

Cyclophosphamide

GVAX

AGEN2373 (RP2D)

Study Details

Brief summary:

The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.

Conditions

Pancreatic Cancer

Study ID

NCT06782932

Start date

May 27, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have a newly diagnosed, biopsy-proven adenocarcinoma of the pancreas.
  • Tumor must be deemed resectable by the study team
  • Patient's acceptance to have a tumor biopsy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
  • For both Women and Men, must use acceptable form of birth control while on study.

Exclusion Criteria:

  • Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
  • Diagnosed with another cancer whose natural history or treatment could interfere with safety or efficacy assessments on this study.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Active autoimmune disease.
  • Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
  • Active infection requiring systemic therapy.
  • Known history of human immunodeficiency virus (HIV).
  • Active or chronic hepatitis B or hepatitis C.
  • Known active tuberculosis.
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
  • Received a live vaccine ≤ 28 days before first dose of study drug.
  • History of severe hypersensitivity reaction to any monoclonal antibody
  • Concurrent participation in another therapeutic clinical study
  • Pregnant or breastfeeding

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - AGEN2373/Balstilimab/Cyclophosphamide/GVAX

experimental: Arm 2 - AGEN2373/Balstilimab/mKRASvax (1.8mg total peptides +0.5mg each poly-ICLC)

Interventions

AGEN2373

1. Up to 3 doses (1 mg/kg, 3 mg/kg, and 10 mg/kg) will be tested in Phase I to determine the dose to be used in Phase II. AGEN2373 will be administered as a 60 minute IV infusion (-5/+15 min) on Day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. Drug: 1 mg/kg, 3 mg/kg, and 10 mg/kg IV

Balstilimab

1. 450 mg will be administered as a 30 minute IV Infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. Drug: 450 mg IV

Cyclophosphamide

1. 200 mg/m2 will be administered as a 30 minute IV infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. Drug: 200 mg/m2 IV

GVAX

1. Vaccine (5 × 108 cells) will be administered on Day 2 of each cycle for a total of 6 cycles of treatment. Six intradermal injections will be given in the upper thighs and non-dominant arms. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. Drug: GVAX

AGEN2373 (RP2D)

1. Drug: Up to 3 doses (1 mg/kg, 3 mg/kg, and 10 mg/kg) will be administered as a 60 minute IV. Infusion (-5/+15 min) on Day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. Drug: 1 mg/kg, 3 mg/kg, and 10 mg/kg IV

Balstilimab

1. 450 mg will be administered as a 30 minute IV. Infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. Drug: 450 mg IV

mKRASvax

1. mKRASvax will be administered on Day 1 of each cycle and on Day 8 of Cycle 1 only. mKRASvax is given as 5 subcutaneous injections administered in the upper thighs and arms. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.
2. 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC

Primary outcome measure

  • Dose Limiting Toxicities in Phase I participants [ Time Frame: 1 month ]
  • Number of participants experiencing Grade 3 or Higher study drug-related toxicities [ Time Frame: 2 years ]
  • Number of participants who form Intratumoral tertiary lymphoid structures (TLS) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Colleen Apostol, RN

410-614-3644GIClinicalTrials@jhmi.edu

Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Colleen Apostol, RN

410-614-3644GIClinicalTrials@jhmi.edu

Principal Investigator:

Eric Christenson, MD

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Keywords

  • Balstilimab
  • AGEN2373
  • KRAS peptide vaccine
  • peptide vaccine
  • Poly-ICLC
  • GVAX
  • Cyclophosphamide
  • Immunotherapy
  • Anti-PD-1 (anti-check point inhibitor)
  • PD-L1 (check point inhibitor)
  • Anti-CD137
  • Cancer vaccine
  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Adenocarcinoma
  • Carcinoma
  • Pancreas
  • mKRASvax

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-12-03.