NCT04137536

Brief Summary

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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

6.5 years

First QC Date

October 21, 2019

Last Update Submit

May 12, 2025

Conditions

Pancreatic CancerAdvanced Pancreatic CancerPancreatic AdenocarcinomaPancreatic Neoplasms

Keywords

EGFR-BATbispecific antibody-armed activated T cellsPancreatic cancermemorial sloan kettering cancer center18-463

Outcome Measures

Primary Outcomes (1)

  • Evaluate toxicity

    The NCI CTEP CTCAE v4.0 will be used.

    1 year

Study Arms (1)

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.

Drug: anti-EGFR-bispecific antibody armed activated T-cells

Interventions

anti-EGFR-bispecific antibody armed activated T-cellsDRUG

Phase I: * First 3 participants, twice weekly infusions of 10\^10 EGFR BATs infusions * If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10\^10. * If \>/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10\^9 per infusion * If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort Expansion cohort: \- 8 infusions of 7.5 x 10\^9 or 10\^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I)

Also known as: EGFR BATs
Pancreatic Adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Virginia (Specimen Analysis)

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Park JA, Santich BH, Xu H, Lum LG, Cheung NV. Potent ex vivo armed T cells using recombinant bispecific antibodies for adoptive immunotherapy with reduced cytokine release. J Immunother Cancer. 2021 May;9(5):e002222. doi: 10.1136/jitc-2020-002222.

    PMID: 33986124DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Kenneth Yu, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 24, 2019

Study Start

October 17, 2019

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(2)