TR-002 for Pancreatic Cancer

Overseen By Selina Laqui

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Cardiovascular disease, Infections, others

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

Compensation: Varies

Number of Visits: 6

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safest dose and identify side effects of a new chemotherapy drug, TR-002, for individuals with advanced pancreatic cancer that cannot be surgically removed and has stopped responding to other treatments. TR-002 may help prevent tumor cells from growing and spreading. The trial seeks participants with pancreatic cancer that has spread and is no longer responding to standard treatments. As a Phase 1 trial, this research focuses on understanding how TR-002 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that TR-002 is likely to be safe for humans?

Research is testing TR-002 for safety in people with advanced pancreatic cancer and other solid tumors. As an early trial, limited information exists about its safety in humans. However, such trials are designed to closely monitor participants' responses to the treatment.

Doctors in these trials look for side effects and assess how well participants tolerate the treatment. TR-002 is administered to a small group to determine the best dose and identify any major issues. Participants receive close monitoring for unwanted side effects.

If TR-002 were unsafe, the trial would stop. The ongoing status of the trial suggests that TR-002 might be well-tolerated so far. However, joining a trial involves risks, so discussing any concerns with the doctors is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, which often include chemotherapy drugs like gemcitabine and nab-paclitaxel, TR-002 offers a new approach by being administered intravenously on a specific schedule designed to maximize its impact. Researchers are excited about TR-002 because it has a unique mechanism that could potentially target cancer cells more effectively, while minimizing damage to healthy cells. This precise delivery method and innovative mechanism of action set TR-002 apart, offering hope for improved outcomes in a condition known for its challenging prognosis.

What evidence suggests that TR-002 might be an effective treatment for pancreatic cancer?

Research has shown that TR-002, the investigational treatment in this trial, stops cancer cells from growing and spreading. This is crucial for treating challenging cases like advanced pancreatic cancer, which often resists standard treatments. Early results suggest that TR-002 might help by targeting and killing these stubborn cancer cells. Although specific data on TR-002's effectiveness for pancreatic cancer is limited, it functions similarly to other chemotherapy drugs that have successfully fought cancer. The hope is that TR-002 will offer a new option for patients with limited choices. ^{2 6 7 8 9}

Who Is on the Research Team?

Edward J Kim, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors or pancreatic adenocarcinoma that has spread and cannot be removed by surgery. Participants must have a type of cancer that hasn't responded to previous treatments. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatment history.

Inclusion Criteria

I am 18 years old or older.

Absolute neutrophil count ≥ 1,000/mcL

Provision of signed and dated informed consent form

Exclusion Criteria

I have changes in my vision or field of view.

I have a history of seizures.

Any other condition that could compromise the subject's safety or put the study outcomes at undue risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive TR-002 intravenously on days 1, 8, 15, and 22 of each 28-day cycle

28 days per cycle

4 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 year

1 visit at 30 days post-treatment, then every 60 days

What Are the Treatments Tested in This Trial?

Interventions

• TR-002

Trial Overview The trial is testing TR-002, a chemotherapy drug intended to kill or stop the growth and spread of tumor cells. This phase I study aims to determine the safest dose with the fewest side effects for treating advanced or metastatic solid tumors and refractory pancreatic adenocarcinoma.

How Is the Trial Designed?

Group I: Treatment (TR-002) Experimental Treatment 1 Intervention

Patients receive TR-002 IV, over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan during screening and undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/c02619bb24cff752/nct07189195-tr-002-treatment-advanced-metastatic-solid-tumors-pancreatic-adenocarcinoma

TR-002 for the Treatment of Advanced, Unresectable or ... This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where ...

2. withpower.com withpower.com/trial/phase-1-refractory-pancreatic-adenocarcinoma-8-2025-d589d

TR-002 for Pancreatic Cancer · Info for Participants This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where it first started ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4684166/

Phase II clinical trials on Investigational drugs for the ... Gemcitabine once again proved to be predictable in benefit and response with a 6.8 months median overall survival and 9.4% response rate. FOLFIRINOX, in ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01965

Randomized Phase II Study of Nab-Paclitaxel and ... The median follow-up period was 8.1 months (IQR, 4.2-13.9). OS6 was 68.6% (95% CI, 56.3 to 78.1) for the Gem/Nab/Toc group and 62.0% (49.6-72.1) ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT228037

Real life data of 601 patients from the QoliXane pancreatic ... Real life data of 601 patients from the QoliXane pancreatic cancer study. ... This is an interim analysis of our data focused on efficacy outcome. Methods ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07189195

Study Details | NCT07189195 | TR-002 for the Treatment of ... This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where ...

7. a2bio.com a2bio.com/a2-biotherapeutics-presents-initial-safety-and-efficacy-data-from-ongoing-phase-1-2-everest-2-study-including-first-report-of-a-complete-response-to-car-t-cell-therapy-in-a-patient-with-nsclc/

A2 Bio Announces First Patient Dosed in Phase 1/2 ... A2 Biotherapeutics Presents Initial Safety and Efficacy Data from Ongoing Phase 1/2 EVEREST-2 Study, Including First Report of a Complete ...

8. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/pancreatic-cancer

Pancreatic Cancer clinical trials at University of California Health The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid ...

9. elicio.com elicio.com/press_releases/elicio-therapeutics-announces-positive-recommendation-by-idmc-to-continue-eli-002-7p-randomized-phase-2-study-in-pancreatic-cancer-without-modifications-to-final-analysis/

Press Release Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without ...