22 Participants Needed

EGFR BATs for Pancreatic Cancer

LL
IV
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Overseen ByAshley Donihee
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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, you cannot be on chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug EGFR BATs for pancreatic cancer?

Research shows that adding EGFR-targeted drugs like erlotinib to chemotherapy in pancreatic cancer has shown some benefit, but the overall improvement in survival is marginal. In some cases, patients with specific genetic mutations in their tumors have responded exceptionally well to EGFR-targeted therapy.12345

What is the safety profile of EGFR-targeting treatments in humans?

EGFR-targeting treatments, like erlotinib, have been used in lung and pancreatic cancer and are generally well tolerated, but they can cause side effects such as diarrhea, skin issues, and fatigue. Serious side effects, though rare, can include lung problems and infections, so it's important for doctors to monitor and manage these risks.678910

How does the EGFR BATs treatment differ from other treatments for pancreatic cancer?

The EGFR BATs treatment is unique because it uses a patient's own T cells, which are modified to target cancer cells by arming them with a bispecific antibody that recognizes EGFR, a protein often overexpressed in pancreatic cancer. This approach aims to enhance the body's immune response against the cancer, potentially improving survival rates compared to traditional chemotherapy or targeted therapies like erlotinib.311121314

What is the purpose of this trial?

This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemotherapy and may have responding, stable or progressive disease. Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6 subjects. The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib).

Research Team

TL

Tri Le, MD

Principal Investigator

University of Virginia

Eligibility Criteria

Adults with pancreatic adenocarcinoma who've had at least one chemo treatment can join this trial. They should have a life expectancy of over 3 months, be in good physical condition, and not planning to get pregnant or father a child. People with serious health issues, recent surgeries, active infections, certain drug treatments within the last few weeks or other cancers in the past 5 years are excluded.

Inclusion Criteria

I have pancreatic cancer that has spread and received chemotherapy.
You are expected to live for at least 3 more months.
I am willing to use effective birth control.
See 4 more

Exclusion Criteria

Treatment with any investigational agent within 14 days prior to first study intervention (apheresis) for protocol therapy
Capability of being compliant, as determined by the PI and investigator team
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3-4 weeks
1 visit (in-person)

Leukapheresis and T-cell Activation

White blood cells are collected and T-cells are activated and armed with bispecific antibodies

2 weeks
1 visit (in-person)

Bridging Chemotherapy

Participants receive one dose of chemotherapy prior to EGFR BATs infusion

1-2 weeks
1 visit (in-person)

Treatment

Participants receive EGFR BATs infusions twice weekly or weekly for a total of 8 or 4 infusions respectively

4 weeks
8 visits (in-person) or 4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
5 visits (in-person)

Treatment Details

Interventions

  • EGFR BATs
Trial Overview The trial is testing EGFR BATs (a type of immune cell therapy) after standard chemotherapy for pancreatic cancer. Phase Ib will find a safe dose through 8 infusions twice weekly for up to 6 subjects. Phase II will assess how well this works in about 22 patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EGFR BATs after standard of care chemoExperimental Treatment1 Intervention
Subjects will undergo apheresis to collect peripheral blood mononuclear cells. Cells will be cultured for up to 2 weeks before activated T-cells will be harvested, armed with EGFR Biarmed activated T-cells, washed to remove unbound EGFRBi, and cryopreserved. Subjects will then receive one dose of standard of care chemotherapy prior to receiving EGFR BATs.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Findings from Research

EGFR inhibitors significantly improve objective response rates (ORR), disease control rates (DCR), and progression-free survival (PFS) in advanced non-small cell lung cancer patients with EGFR mutations compared to non-targeted chemotherapy, based on a review of 21 studies involving 4,250 patients.
Despite the improved response and control rates with EGFR inhibitors, overall survival (OS) did not show significant differences compared to non-targeted chemotherapy or older EGFR inhibitors, indicating that better short-term outcomes do not necessarily translate to longer survival.
Efficacy and Safety of EGFR Inhibitors in the Treatment of EGFRPositive NSCLC Patients: A Meta-Analysis.Dang, A., Dang, S., Vallish, BN.[2021]
In a pooled analysis of 21 clinical trials involving 1468 patients with EGFR mutation-positive non-small cell lung cancer, afatinib was found to cause significantly more severe adverse events, such as rash and diarrhea, compared to erlotinib and gefitinib.
Gefitinib was associated with a higher frequency of severe hepatotoxicity compared to the other two drugs, while the overall rates of severe interstitial lung disease were low and similar across all three EGFR-TKIs.
Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer.Takeda, M., Okamoto, I., Nakagawa, K.[2022]
Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) significantly enhance progression-free and overall survival in patients with non-small cell lung cancer (NSCLC) who have activating mutations in the EGFR gene.
Despite their efficacy, EGFR-TKIs can cause several adverse events, such as diarrhea, liver toxicity, and skin issues, which can negatively impact patients' quality of life and adherence to treatment; therefore, managing these side effects is crucial for effective therapy.
Safety of EGFR-TKIs for EGFR mutation-positive non-small cell lung cancer.Zhou, JY., Liu, SY., Wu, YL.[2021]

References

Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group. [2023]
Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. [2023]
Exceptional response to Erlotinib monotherapy in EGFR Exon 19-deleted, KRAS wild-type, Chemo-refractory advanced pancreatic adenocarcinoma. [2022]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Targeting EGFR in pancreatic cancer treatment. [2021]
Targeting the Epidermal Growth Factor Receptor in Addition to Chemotherapy in Patients with Advanced Pancreatic Cancer: A Systematic Review and Meta-Analysis. [2023]
6.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of EGFR Inhibitors in the Treatment of EGFRPositive NSCLC Patients: A Meta-Analysis. [2021]
Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. [2022]
A benefit-risk assessment of erlotinib in non-small-cell lung cancer and pancreatic cancer. [2021]
Safety of EGFR-TKIs for EGFR mutation-positive non-small cell lung cancer. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Nondermatologic adverse events associated with anti-EGFR therapy. [2018]
A phase II trial of gemcitabine and erlotinib followed by ChemoProton therapy plus capecitabine and oxaliplatin for locally advanced pancreatic cancer. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical and immune responses to anti-CD3 x anti-EGFR bispecific antibody armed activated T cells (EGFR BATs) in pancreatic cancer patients. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Epidermal growth factor receptor (EGFR) is highly conserved in pancreatic cancer. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
In vivo therapeutic synergism of anti-epidermal growth factor receptor and anti-HER2 monoclonal antibodies against pancreatic carcinomas. [2019]
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