Study on TG01 Vaccine and QS-21 with or without Balstilimab as Maintenance Therapy After Chemotherapy in Patients with Resected Pancreatic Cancer

Sponsor: University of Kansas Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05638698

Provider View

This clinical trial is exploring whether the experimental drug TG01, alone or combined with Balstilimab, can help the immune system fight off any remaining cancer cells in patients who have had surgery for pancreatic cancer. The study also uses QS-21 to enhance the effects of TG01.

Patient Parameters

Program Overview

The purpose of this study is to find out if the new drug TG01 can work with the body's immune system to attack any leftover cancer cells after surgery for pancreatic cancer. Researchers are also testing if combining TG01 with another drug, Balstilimab, can be even more effective. Both TG01 and Balstilimab are experimental and not yet approved by the FDA for treating pancreatic cancer or any other cancer. QS-21, which is approved for use in a shingles vaccine, is included in the study to boost the action of TG01. Participants will have regular visits during treatment, follow-up visits about 30 and 90 days after the last dose, and long-term follow-up for about a year.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and be willing to sign a consent form.
  • Men and women aged 18 years or older.
  • Must have a good performance status (ECOG 0-1) within 28 days before joining the study.
  • Must have had surgery for stage I, II, or III pancreatic cancer.
  • Must have a life expectancy of at least 6 months.
  • Must have a specific RAS gene mutation in the tumor tissue.
  • No signs of cancer returning on imaging tests.
  • Must test positive for minimal residual disease (MRD) despite previous treatments.
  • Must have completed prior cancer treatment at least 14 days before joining the study and recovered from any side effects.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must have adequate organ function based on specific blood tests.
  • Must agree to use effective birth control during the study and for a period after the last dose of the study drugs.

Exclusion Criteria

  • Currently enrolled in another treatment study.
  • Using or planning to use other cancer treatments during this study.
  • Have a psychiatric condition or social situation that would prevent following study requirements.
  • Pregnant, planning to become pregnant, or breastfeeding.
  • Allergic to any ingredients in the study drugs.
  • Have taken an investigational drug within 4 weeks before starting the study.
  • Taking medications that affect the immune system, unless at low doses.
  • Have serious illnesses or medical conditions, such as uncontrolled infections or heart failure.
  • Have a history of autoimmune diseases or inflammatory bowel disease.
  • Have had adverse reactions to peptide vaccines.
  • Test positive for HIV or hepatitis B or C.
  • Planning to receive live vaccines during the study.
  • Have other active cancers that may need treatment within 3 years.

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