393 Participants Needed

Zolbetuximab + Chemotherapy for Pancreatic Cancer

Recruiting at 167 trial locations
AP
Overseen ByAstellas Pharma Global Development
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Astellas Pharma Global Development, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you need to take medicines that suppress your immune system or if you have recently taken certain treatments like radiotherapy or investigational drugs. It's best to discuss your specific medications with the study doctor.

What data supports the effectiveness of the drug Zolbetuximab + Chemotherapy for Pancreatic Cancer?

Research shows that combining nab-paclitaxel (a form of chemotherapy) with gemcitabine significantly improves survival in patients with advanced pancreatic cancer. This combination has become a standard treatment option due to its effectiveness in increasing overall and progression-free survival.12345

Is the combination of Zolbetuximab and chemotherapy safe for treating pancreatic cancer?

The combination of nab-paclitaxel (a form of chemotherapy) and gemcitabine has been shown to be generally safe for treating pancreatic cancer, with manageable side effects like neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage). These side effects were mostly mild and resolved with dose adjustments.34678

What makes the drug Zolbetuximab + Chemotherapy unique for treating pancreatic cancer?

The combination of Zolbetuximab with chemotherapy, including nab-paclitaxel and gemcitabine, is unique because nab-paclitaxel is an albumin-bound formulation that avoids the toxicities of traditional solvents and has shown improved survival rates in pancreatic cancer patients compared to gemcitabine alone. This combination leverages novel drug delivery technology to enhance treatment efficacy.257910

What is the purpose of this trial?

Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for people with pancreatic cancer.There is an unmet medical need to treat people with pancreatic cancer. This study will help find the dose of zolbetuximab to be used with chemotherapy and provide more information on this treatment in adults with metastatic pancreatic cancer. The study is currently ongoing globally. People in this study will be treated with either zolbetuximab and chemotherapy or chemotherapy by itself.The study's main aims are to find a suitable dose of zolbetuximab to be used with chemotherapy in the second part of this study, to check if zolbetuximab and chemotherapy compared to chemotherapy by itself can improve the survival of people with pancreatic cancer, and to check the safety of zolbetuximab when given with chemotherapy and how well people cope with medical problems during the study.Adults with metastatic pancreatic cancer can take part. Their cancer is metastatic, has the CLDN18.2 marker in a tumor sample and has not previously been treated with chemotherapy. Metastatic means the cancer has spread to other parts of the body. People cannot take part are if they have recently had radiotherapy and have not recovered, need to take medicines to suppress their immune system, have history of nervous system metastases from their pancreatic cancer, or they have other active cancers that need treatment. People who have a specific heart condition or infections also cannot take part.This study will be in 2 parts. Part 1 is called the Safety Lead-in Phase. Groups of people will receive 1 of 2 different doses of zolbetuximab: a lower dose or a higher dose, both together with chemotherapy. A medical expert panel will check the results and decide the dose to use in Part 2.Part 2 is called the Randomization Phase. People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself. The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself. In both parts of the study, zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein. This is called an infusion. Each treatment cycle is 4 weeks (28 days) long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle. People will visit the clinic on certain days during their treatment. The study doctors will check for any medical problems from zolbetuximab. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken before treatment if a previous sample is not available. People will have the option of giving a tumor sample after treatment has finished. People will visit the clinic after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

Research Team

MD

Medical Director

Principal Investigator

Astellas Pharma Global Development

Eligibility Criteria

This trial is for adults with metastatic pancreatic adenocarcinoma that tests positive for CLDN18.2 and haven't had chemotherapy before. They should have a life expectancy of at least 12 weeks, be able to follow contraceptive guidelines, and not be pregnant or breastfeeding. People who've had certain recent treatments or surgeries, active infections, other cancers needing treatment, severe allergies to study drugs' components, or specific heart conditions can't join.

Inclusion Criteria

Subject agrees not to participate in other interventional studies while receiving study drug in present study.
I have a tumor that can be measured and it's either outside the area treated with radiation or has grown after radiation.
Subject has predicted life expectancy ≥ 12 weeks.
See 24 more

Exclusion Criteria

I have severe fluid buildup in my chest or abdomen.
You can participate in the study if your hepatitis C blood test shows that you had the infection in the past, but the virus is not currently in your body.
I do not have active hepatitis B according to my test results.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in Phase

Participants receive one of two different doses of zolbetuximab with chemotherapy to establish the recommended dose for the next phase.

4 weeks
Multiple visits for infusions and monitoring

Randomization Phase

Participants are randomized to receive either zolbetuximab with chemotherapy or chemotherapy alone. Treatment cycles are 4 weeks long.

Up to 65 months
Regular visits for infusions, health checks, and scans

Follow-up

Participants are monitored for safety and effectiveness after treatment, including health checks and blood tests.

Up to 65 months
Clinic visits post-treatment

Treatment Details

Interventions

  • Gemcitabine
  • Nab-paclitaxel
  • Zolbetuximab
Trial Overview The trial is testing the effectiveness and safety of a drug called zolbetuximab combined with Nab-Paclitaxel and Gemcitabine as the first line of treatment. It aims to confirm the best dose for phase 2 trials, measure how long patients live while on this treatment, monitor side effects, check how their bodies process the drugs (pharmacokinetics), and assess any changes in their quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: zolbetuximab +nab-paclitaxel + gemcitabineExperimental Treatment3 Interventions
Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Group II: nab-paclitaxel + gemcitabineActive Control2 Interventions
Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Ovarian cancer
  • Non-small cell lung cancer
🇺🇸
Approved in United States as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Ovarian cancer
  • Non-small cell lung cancer
🇨🇦
Approved in Canada as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Ovarian cancer
  • Non-small cell lung cancer
🇯🇵
Approved in Japan as Gemzar for:
  • Pancreatic cancer
  • Breast cancer
  • Ovarian cancer
  • Non-small cell lung cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials
204
Recruited
123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura profile image

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Findings from Research

In a phase 3 trial involving 861 patients with metastatic pancreatic cancer, the combination of nab-paclitaxel and gemcitabine significantly improved overall survival (8.5 months) compared to gemcitabine alone (6.7 months), with a hazard ratio for death of 0.72, indicating a 28% reduction in the risk of death.
The combination therapy also resulted in better progression-free survival (5.5 months vs. 3.7 months) and a higher overall response rate (23% vs. 7%), although it was associated with increased rates of adverse events like neutropenia and neuropathy.
Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine.Von Hoff, DD., Ervin, T., Arena, FP., et al.[2022]
The combination of nab-paclitaxel, gemcitabine, and capecitabine was found to be well tolerated in a phase I study with 15 patients, establishing a maximum-tolerated dose (MTD) but showing only modest antitumor activity in metastatic pancreatic cancer.
Despite the regimen being generally safe, with a low incidence of severe hematologic toxicities, only 14.3% of patients had a partial response, indicating that optimizing dose intensity may be crucial for improving treatment outcomes.
A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer.Ko, AH., Truong, TG., Kantoff, E., et al.[2022]
In a small study of 6 women with heavily pretreated HER2-negative metastatic breast cancer, the combination of nab-paclitaxel (nab-P) and bevacizumab (B), with or without gemcitabine (G), showed promising safety and preliminary efficacy, with only one patient experiencing significant toxicity.
Out of the 6 patients, 2 achieved partial responses and 4 had stable disease, indicating that this combination therapy may be effective, warranting further investigation in a formal phase II trial.
Paclitaxel albumin-bound particles (abraxane) in combination with bevacizumab with or without gemcitabine: early experience at the University of Miami/Braman Family Breast Cancer Institute.Lobo, C., Lopes, G., Silva, O., et al.[2022]

References

Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. [2022]
A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]
Paclitaxel albumin-bound particles (abraxane) in combination with bevacizumab with or without gemcitabine: early experience at the University of Miami/Braman Family Breast Cancer Institute. [2022]
nab-Paclitaxel for the treatment of pancreatic cancer. [2023]
[Nab-Paclitaxel plus Gemcitabine Hydrochloride in Patients with Metastatic or Recurrent Pancreatic Cancer - A Single Institution Experience]. [2022]
A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. [2022]
Albumin-bound paclitaxel: a review of its use for the first-line combination treatment of metastatic pancreatic cancer. [2021]
Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. [2022]
The winning formulation: the development of paclitaxel in pancreatic cancer. [2022]
Nab-paclitaxel: potential for the treatment of advanced pancreatic cancer. [2021]
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