84 Participants NeededMy employer runs this trial

ANO31905 + Chemotherapy for Pancreatic Cancer

Recruiting at 3 trial locations
LZ
TZ
Overseen ByTiana Zhao
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ANO31905, combined with chemotherapy, to determine its safety and effectiveness for people with a specific type of pancreatic cancer. The trial targets those with advanced cancer that cannot be surgically removed. Eligible participants must have a confirmed diagnosis of extensive or metastatic pancreatic ductal adenocarcinoma, with cancer testing positive for the CLDN18.2 marker. Participants should not have received prior treatment for their advanced cancer. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of gemcitabine and nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is generally well-tolerated for treating pancreatic cancer. Studies have found that patients using this combination tend to live longer compared to those using gemcitabine alone. However, risks such as blood clots and bleeding exist.

For the combination of ANO31905 with modified FOLFIRINOX, research suggests it is a practical option with a relatively low risk of severe side effects. Most patients can handle the treatment without major issues, though some side effects may still occur, as with any treatment. Discussing potential risks with healthcare providers before joining a trial is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ANO31905 for pancreatic cancer because it introduces a novel approach when combined with established chemotherapy drugs like Gemcitabine and Nanoparticle Albumin-Bound Paclitaxel. ANO31905 stands out due to its unique mechanism of action, which targets specific cancer cell pathways that standard treatments do not. Unlike the standard of care, such as FOLFIRINOX, which relies on a combination of traditional chemotherapeutic agents, ANO31905 aims to enhance the effectiveness of chemotherapy by potentially making cancer cells more sensitive to treatment. This could lead to improved outcomes for patients with pancreatic cancer, offering hope for more effective management of this challenging condition.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research shows that gemcitabine, a chemotherapy drug, can help treat pancreatic cancer by increasing the number of patients who survive for at least one year. Previous studies have shown it to be effective in about 21% of certain cancer cases. In this trial, one group of participants will receive ANO31905 combined with gemcitabine and nanoparticle albumin-bound paclitaxel.

Another group will receive ANO31905 combined with the mFOLFIRINOX treatment, which uses several chemotherapy drugs and has been found to help patients live longer without their cancer worsening compared to using gemcitabine alone. This treatment has shown promising results in advanced pancreatic cancer, with some patients living up to 30 months. Combining these treatments with ANO31905 might enhance their effectiveness against pancreatic cancer, although the specific effects of ANO31905 are still under investigation.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic pancreatic cancer that cannot be removed by surgery and whose tumors test positive for CLDN18.2. Participants must have good general health, working major organs, at least one measurable tumor, and not be pregnant or breastfeeding.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity only.
My organs are working well based on recent tests.
I am 18 years old or older.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ANO31905 in combination with chemotherapy as the first-line treatment

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ANO31905
  • Gemcitabine
  • Nanoparticle Albumin-Bound Paclitaxel

Trial Overview

The study is testing a new drug called ANO31905 combined with standard chemotherapy drugs (nab-paclitaxel and gemcitabine) as the first treatment for this type of pancreatic cancer. The goal is to see if adding ANO31905 improves outcomes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ANO31905+mFOLFIRINOXExperimental Treatment2 Interventions
Group II: ANO31905+AGExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anova Innovation Limited

Lead Sponsor

Citations

Gemcitabine

Gemcitabine is a type of chemotherapy drug. It is a treatment for a number of different cancers. Read about the side effects and other important ...

Gemcitabine Hydrochloride - NCI

It disrupts DNA formation by mimicking a DNA building block. This slows or stops the growth of cancer cells and other rapidly growing cells. US ...

Gemcitabine

During the early 1990s gemcitabine was studied in clinical trials. The pancreatic cancer trials found that gemcitabine increased one-year survival rate ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10048477/

Gemcitabine in locally advanced and metastatic non-small ...

Of the 80 patients enrolled, 76 were evaluable for efficacy analysis, and 16 patients had a partial response for an overall response rate of 21.1% (95% CI, 11.9 ...

Gemcitabine (intravenous route) - Side effects & uses

Gemcitabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30523758/

Phase I/II Trial to Evaluate the Efficacy and Safety of ...

Gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA) significantly improved survival compared with gemcitabine

Study Details | NCT07444541 | ANO31905 in Combination ...

The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects

ABRAXANE® for Metastatic Pancreatic Cancer | for HCPs

The multinational, randomized, Phase III MPACT study compared ABRAXANE + gemcitabine vs gemcitabine alone as first-line treatment in 861 patients with mPC with ...

Nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic ...

Patients who received the drug combination had a median overall survival of 8.5 months, compared with 6.7 months for patients treated with ...

ANO31905 in Combination With Chemotherapy for CLDN18.2 ...

The goal of this clinical trial is to assess the safety and efficacy of ANO31905. Presence risks of thrombosis or bleeding;