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APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery

Safety and Immunologic Activity of Multiple Infusions of APN401

NCT03087591•Wake Forest University Health Sciences

Summary

This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401). SECONDARY OBJECTIVES: I. To determine the immunologic effects of multiple infusions of APN401. II. To document clinical response and survival. OUTLINE: Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with histologically confirmed inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have either:
•* Failed to respond to standard therapy or
•* For whom no standard therapy is available or
•* Refuse to receive standard therapies
•The study is intended to enroll patients with pancreatic and colorectal cancer; patients with other types of solid tumors will require approval by the principal investigator
•Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
•Patients with treated, stable, and asymptomatic brain metastases are eligible
•Patients on every 3 or every 4 week systemic therapy programs must be at least 4 weeks since treatment and recovered from any clinically significant toxicity experienced; patients on weekly or daily systemic therapy programs and patients receiving radiation must be at least 1 week since treatment and recovered from any clinically significant toxicity experienced; must be at least 4 weeks and have recovered from major surgery
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•White blood cells \>= 3000/uL
+17 more criteria

Exclusion Criteria

•Women must not be pregnant or breastfeeding; all women of childbearing potential must have a blood test within 72 hours to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
•Untreated, progressing, or symptomatic brain metastases

Locations (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Key Dates

Start Date

April 28, 2017

Primary Completion Date

July 31, 2019

Completion Date

December 8, 2020

Last Updated

October 10, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Malignant Neoplasm in the BrainMetastatic Solid NeoplasmRecurrent Colorectal CarcinomaRecurrent Pancreatic CarcinomaRecurrent Solid NeoplasmStage IV Colorectal CancerStage IV Pancreatic CancerStage IVA Colorectal CancerStage IVA Pancreatic CancerStage IVB Colorectal CancerStage IVB Pancreatic CancerUnresectable Solid Neoplasm

Interventions

Laboratory Biomarker Analysis

OTHER

siRNA-transfected Peripheral Blood Mononuclear Cells (PBMC) APN401

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery

Inclusion Criteria

Exclusion Criteria

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

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