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A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

NCT04137536 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

anti-EGFR-bispecific antibody armed activated T-cells

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)

Sponsors & Collaborators

Principal Investigators

  • Kenneth Yu, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137536 on ClinicalTrials.gov