81 Participants Needed

Botensilimab + Chemotherapy for Pancreatic Cancer

Recruiting at 36 trial locations
AI
Overseen ByAgenus, Inc. Clinical Trial Information
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 protocol does not specify if you must stop taking your current medications. However, certain treatments like cytotoxic agents, monoclonal antibodies, and small molecule therapies must be stopped within specific time frames before starting the study drugs.

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

Research shows that combining nab-paclitaxel (a form of paclitaxel) with gemcitabine has significantly improved survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. This suggests that the combination of these drugs can be effective in treating pancreatic cancer.12345

Is the combination of Botensilimab and chemotherapy safe for humans?

The combination of nab-paclitaxel (a form of paclitaxel) and gemcitabine has been studied for pancreatic cancer, showing it is generally safe for use in humans, including elderly patients. These drugs are FDA-approved for cancer treatment, and studies have shown they can be used together safely.12678

What makes the drug Botensilimab + Chemotherapy unique for pancreatic cancer?

The combination of Botensilimab with chemotherapy, including nab-paclitaxel and gemcitabine, is unique because nab-paclitaxel (a special formulation of paclitaxel) has shown improved survival rates in pancreatic cancer patients compared to gemcitabine alone, highlighting the importance of novel drug delivery technology in enhancing treatment efficacy.145910

What is the purpose of this trial?

This trial is testing whether adding a new drug, botensilimab, to standard chemotherapy can better treat patients with advanced pancreatic cancer. The study will ensure the new drug is safe and determine the right dose. It will also compare the effectiveness of the new combination treatment to chemotherapy alone.

Research Team

MD

Medical Director

Principal Investigator

Agenus Inc.

Eligibility Criteria

This trial is for adults with metastatic pancreatic cancer who have already tried FOLFIRINOX treatment. They should be relatively healthy otherwise, with a life expectancy of at least 3 months and able to perform daily activities (ECOG status 0 or 1). Participants must not have other active cancers or serious illnesses, no history of severe allergies to study drugs, and agree to use effective contraception.

Inclusion Criteria

My diagnosis is pancreatic cancer confirmed by tissue analysis.
My organs are working well.
I am a woman who can have children and have a negative pregnancy test.
See 7 more

Exclusion Criteria

I have not received a COVID-19 vaccine in the week before starting the study drugs.
I have had more than one treatment for my metastatic disease.
I have been treated with drugs that boost the immune system.
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Participants receive botensilimab in combination with standard-of-care chemotherapy to establish safety and dose for Part 2

8 weeks

Treatment

Participants receive either botensilimab with chemotherapy or chemotherapy alone

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Botensilimab
  • Gemcitabine
  • Nab-paclitaxel
Trial Overview The study is testing the effectiveness of Botensilimab when added to standard chemotherapy (Gemcitabine and Nab-paclitaxel) versus chemotherapy alone in treating metastatic pancreatic cancer. Patients are divided into two groups: one receiving only chemotherapy and the other receiving both Botensilimab and chemotherapy.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: CombinationExperimental Treatment3 Interventions
Participants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Group II: Part 1: Combination (Safety Lead-in Phase)Experimental Treatment3 Interventions
Participants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Group III: Part 2: Standard of CareActive Control2 Interventions
Participants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

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?

Agenus Inc.

Lead Sponsor

Trials
58
Recruited
4,900+

Findings from Research

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]
Gemcitabine-loaded human serum albumin nanoparticles (Gem-HSA-NPs) were successfully developed and showed a favorable controlled release, with an encapsulation rate of approximately 83% and a particle size of about 150 nm.
In vivo studies demonstrated that Gem-HSA-NPs significantly inhibited tumor growth in pancreatic cancer while exhibiting lower toxicity compared to other treatment groups, indicating their potential as a safer and more effective delivery method for gemcitabine.
An in vitro and in vivo study of gemcitabine-loaded albumin nanoparticles in a pancreatic cancer cell line.Yu, X., Di, Y., Xie, C., et al.[2022]
A phase I study is being conducted to evaluate the safety and determine the maximum tolerated dose of albumin-bound paclitaxel (ABP) delivered via pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with advanced peritoneal metastases from various cancers.
The study will involve three treatments with ABP, escalating the dose from 35 to 140 mg/m², and will assess not only toxicity but also factors like surgical morbidity and quality of life, aiming to set the stage for future randomized phase II trials.
Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane™) for peritoneal carcinomatosis - a phase I first-in-human study.Van De Sande, L., Graversen, M., Hubner, M., et al.[2023]

References

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]
An in vitro and in vivo study of gemcitabine-loaded albumin nanoparticles in a pancreatic cancer cell line. [2022]
Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane™) for peritoneal carcinomatosis - a phase I first-in-human study. [2023]
Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. [2022]
Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2. [2022]
A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced 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]
The winning formulation: the development of paclitaxel in pancreatic cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Nab-Paclitaxel Plus S-1 Shows Increased Antitumor Activity in Patient-Derived Pancreatic Cancer Xenograft Mouse Models. [2017]
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