NCT03165994

APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers

A Phase 2 Study of APX005M in Combination With Concurrent Chemoradiation as Neoadjuvant Therapy for Resectable Esophageal and Gastroesophageal Junction Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Apexigen America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in treating patients with esophageal cancer or GE cancer than can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

Primary Objective: To assess the efficacy of this novel combination, as measured by the pathologic complete response (pCR) rate. Secondary Objectives: 1. To further characterize the safety and feasibility of combining APX005M with SOC chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and GE junction cancers. 2. To assess the efficacy of combining APX005M with SOC chemoradiation as measured by rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery); and radiographic/metabolic response to neoadjuvant treatment on CT-PET. Exploratory Objectives: 1. To identify possible predictive molecular or immune-based efficacy biomarkers for this novel combination. 2. To characterize and assess overall survival.

Conditions

• Esophageal Cancer
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	APX005M	APX005M IV infusion
RADIATION	Radiation Therapy	Radiation therapy, total dose 5040cGy in 180cGy fractions
DRUG	Paclitaxel	Paclitaxel IV infusion
DRUG	Carboplatin	Carboplatin IV infusion
PROCEDURE	Surgical resection of tumor	Surgical removal of the tumor will occur between weeks 10-17

Timeline

• Start date: 2017-10-06
• Primary completion: 2022-11-10
• Completion: 2023-02-21
• First posted: 2017-05-24
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study