GP-2250 + Gemcitabine for Pancreatic Cancer

Recruiting at 8 trial locations

Overseen By Kathryn M Martin, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Geistlich Pharma AG

Must be taking: Gemcitabine

Disqualifiers: Active malignancy, Lung disease, Cardiovascular disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, GP-2250, combined with gemcitabine for patients with advanced pancreatic cancer who haven't responded to other treatments. The goal is to see if this combination works better than existing options. Gemcitabine has been widely used in the treatment of advanced pancreatic cancer, often in combination with other drugs to improve results.

Who Is on the Research Team?

Anup Kasi, MD

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

Adults over 18 with advanced pancreatic cancer that's unremovable or has spread, and who've had certain previous chemotherapies can join. They need a measurable tumor, good blood counts, organ function, and must use effective birth control. Exclusions include recent other cancers (except some skin/breast/cervical), heart disease, lung conditions, major surgery within the last month, or COVID-19 recently.

Inclusion Criteria

- Aspartate aminotransferase (AST), (Serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT), and (Serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastasis

- International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN

My doctor agrees I can be treated with gemcitabine for my pancreatic cancer.

Exclusion Criteria

I have not had major surgery, except for a biopsy, in the last 4 weeks.

First degree relative of the investigator, study staff or the sponsor.

I have only been diagnosed with pancreatic cancer in the last 2 years, except for certain skin, breast, or cervical cancers treated to cure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy

GP-2250 is administered as a single-dose monotherapy during Cycle 1

4 weeks

3 visits (in-person)

Combination Therapy

Participants receive GP-2250 in combination with gemcitabine in subsequent cycles

6-12 months

3 visits per 28-day cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12-24 months

What Are the Treatments Tested in This Trial?

Interventions

• GP-2250

Trial Overview The trial is testing GP-2250 combined with gemcitabine in patients who have previously been treated with fluorouracil-based chemotherapy for their pancreatic cancer. It's a phase 1 trial to see what doses are safe and how well patients tolerate this combination treatment.

How Is the Trial Designed?

Group I: GP-2250 Monotherapy Experimental Treatment 1 Intervention

GP-2250 in doses of 250 mg up to 30 grams intravenously on Days -7, 1, 8, 15 (Cycle 1) and Cycle 2 and all subsequent cycles on Days 7, 8, 15 of a 28-day cycle with gemcitabine 1000 mg/m2 on Days 1, 8, 15 days of the cycle.

Who Is Running the Clinical Trial?

Geistlich Pharma AG

Lead Sponsor

Trials

45

Recruited

2,300+

Translational Drug Development

Collaborator

Trials

19

Recruited

1,000+