CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Aldesleukin +9 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02620865
NCT02620865Phase 2Completed

Phase Ib/II Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) in Combination With Low Dose IL-2 and GM-CSF

Barbara Ann Karmanos Cancer Institute·interventional·Posted Dec 3, 2015·Updated May 15, 2023

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Antibody Therapy, and 8 other interventions for Metastatic Pancreatic Adenocarcinoma and 3 related conditions. Completed, enrolled 2 participants across 1 site.

Detailed Summary

This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed activated T-cells when given together with aldesleukin and sargramostim and to see how well they work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Bispecific antibody armed activated T-cells are the patient's own T cells that are coated with a bispecific antibody comprising 2 antibodies chemically joined together. These antibodies have specific targets and binding properties that may give the T cells a greater ability to seek out, attach to, and kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 3, 2015
Enrollment StartDec 1, 2015
Primary CompletionJun 21, 2021
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.6 years ago

Interventions

Aldesleukinbiological

Given SC

Antibody Therapybiological

Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV

Fluorouracildrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Irinotecan Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV

Oxaliplatindrug

Given IV

Paclitaxel Albumin-Stabilized Nanoparticle Formulationdrug

Given IV

Sargramostimbiological

Given SC