GP-2250 + Gemcitabine for Pancreatic Cancer

Not currently recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, GP-2250, combined with gemcitabine, for individuals with advanced pancreatic cancer. The main goal is to determine the appropriate dosage and assess the safety of this combination. The trial seeks participants whose pancreatic cancer has not improved after previous chemotherapy treatments, specifically those who have tried a 5-fluorouracil-based regimen and experienced disease progression. Those who have undergone prior pancreatic cancer treatments and are now eligible for gemcitabine may consider participating. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, any chemotherapy must be stopped at least 3 weeks before starting the trial, and other anti-cancer therapies must be stopped 4 weeks before. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that GP-2250 in combination with gemcitabine is likely to be safe for humans?

Research has shown that the combination of GP-2250 and gemcitabine appears safe in early studies. An initial review found that patients generally tolerated this treatment well, with no unexpected or severe side effects, indicating good safety.

This study is in a very early phase, marking the first time GP-2250 is tested in humans. This phase aims to determine the treatment's safety and identify the best dose. Although information on reactions remains limited, the absence of major safety concerns is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about GP-2250 for pancreatic cancer because it offers a new approach compared to traditional treatments like surgery, radiation, and chemotherapy. GP-2250 is unique as it targets cancer cells in a different way; it can be administered intravenously at varying doses, from 250 mg up to 30 grams. This flexibility in dosing, combined with its novel mechanism of action, could potentially enhance its effectiveness when used alongside gemcitabine, a standard chemotherapy drug. This combination aims to improve outcomes and provide a fresh alternative for patients battling this challenging disease.

What evidence suggests that GP-2250 combined with gemcitabine might be an effective treatment for pancreatic cancer?

Research has shown that GP-2250, when combined with gemcitabine, might help treat pancreatic cancer. In this trial, participants will receive GP-2250 alongside gemcitabine. Studies have found that this combination can shrink pancreatic tumors more effectively than either treatment alone. It targets the cancer cells' energy supply and disrupts essential processes they need to survive. Early tests demonstrated that GP-2250 reduces energy in cancer cells, helping to stop their growth. These initial findings suggest that this combination could be a promising option for people with pancreatic cancer. ^{1 2 4 5 6}

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

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

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

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+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4177

Interim open-label phase 1 results of misetionamide (GP- ... GP-2250 is a novel antineoplastic agent demonstrating effective activity on preclinical pancreatic cancer models alone or in combination with gemcitabine.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339077/

GP‐2250, a novel anticancer agent, inhibits the energy ... GP‐2250, a novel anticancer agent, inhibits the energy metabolism, activates AMP‐Kinase and impairs the NF‐kB pathway in pancreatic cancer cells.

3. ecancer.org ecancer.org/en/news/23682-preclinical-data-of-gp-2250-to-treat-pancreatic-cancer

Preclinical data of GP-2250 to treat pancreatic cancer Results of the preclinical study showed that at the lowest dose of GP-2250 tested (250 μM), a significant decrease in ATP was apparent at 6 ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT351540

A phase 1/2 study to evaluate the safety, tolerability, and ... In combination with gemcitabine, a synergistic effect was shown with greater inhibition of pancreatic tumor growth than with either gemcitabine or GP-2250 alone ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03854110

Study Details | NCT03854110 | Trial to Evaluate Safety and ... This is a phase 1 first in human, dose escalation trial of GP-2250 administered in combination with gemcitabine in subjects with advanced pancreatic cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11275110/

Maintenance Therapy for Pancreatic Cancer, a New Approach ... The preliminary data on the impact of GP-2250 on CD133+ cells open a new avenue to assess the mechanism of synergy between GP-2250 and Gemcitabine.