Description:
The purpose of this study is to find the safest dose and identify any bad side effects of
EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic
cancer who have already received first-line standard chemotherapy.
Title
- Brief Title: A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
- Official Title: Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Clinical Trial IDs
- ORG STUDY ID:
18-463
- NCT ID:
NCT04137536
Conditions
- Pancreatic Cancer
- Advanced Pancreatic Cancer
- Pancreatic Adenocarcinoma
- Pancreatic Neoplasms
Interventions
Drug | Synonyms | Arms |
---|
anti-EGFR-bispecific antibody armed activated T-cells | EGFR BATs | Pancreatic Adenocarcinoma |
Purpose
The purpose of this study is to find the safest dose and identify any bad side effects of
EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic
cancer who have already received first-line standard chemotherapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Pancreatic Adenocarcinoma | Experimental | Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment. | - anti-EGFR-bispecific antibody armed activated T-cells
|
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic
pancreatic cancer who have received at least first line chemotherapy. Disease
stability or progression during or within 6 months after treatment with 5-Fluorouracil
(5-FU)- or gemcitabine-based chemotherapy. KPS>/= 70% or SWOG performance Status 0 or
1
- Evaluable disease by iRECIST criteria
- Absolute Neutrophil Count (ANC) >/= 1,000/mm^3
- Lymphocyte count >/= 400/mm^3
- Platelet Count >/= 75,000/mm^3
- Hemoglobin >/= 8 g/dL
- Serum Creatinine < 2.0 mg/dl, Creatinine Clearance >/=50 ml/mm (can be calculated or
measured)
- Total Bilirubin </= 2 mg/dl (biliary stent is allowed)
- SGPT and SGOT <5.0 times normal
- LVEF >/= 55% at rest (<UGA or Echo)
- Age >/= 18 years at the time of consent (Written informed consent and HIPAA
authorization for release of personal health information)
- Females of childbearing potential, and males, must be willing to use an effective
method of contraception
- Females of childbearing potential must have a negative pregnancy test within 7 days of
being registered for protocol therapy
Exclusion Criteria:
- Any chemotherapy related toxicities from prior treatment, > grade 2 per CTCAE v4.0
- Known hypersensitivity to cetuximab or other EGFR antibody
- Treatment with any investigational agent within 14 days prior to being registered for
protocol therapy
- Symptomatic brain metastasis
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of trial treatment. Steroid premedication for imaging scans is allowed. Replacement
therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy
for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
treatment.
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy
or significant traumatic injury within 28 days prior to being registered for protocol
therapy
- Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
hepatitis
- Known HIV infection
- Active bleeding or a pathological condition that is associated with a high risk of
bleeding (therapeutic anticoagulation is allowed)
- Has an active infection requiring systemic therapy
- A serious uncontrolled medical disorder that in the opinion of the Investigator may be
jeopardized by the treatment with protocol therapy.
- Females must not be breastfeeding
- Patient may be excluded if, in the opinion of the PI and investigator team, the
patient is not capable of being compliant
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Evaluate toxicity |
Time Frame: | 1 year |
Safety Issue: | |
Description: | The NCI CTEP CTCAE v4.0 will be used. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- EGFR-BAT
- bispecific antibody-armed activated T cells
- Pancreatic cancer
- memorial sloan kettering cancer center
- 18-463
Last Updated
May 20, 2021