INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

April 24, 2020

Primary Completion Date

December 5, 2025

Study Completion Date

December 5, 2025

Conditions
Locally Advanced Rectal Adenocarcinoma
Interventions
DRUG

APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days

"1. APX005M 0.3mg/kg intravenously on day 3 of radiation and on day 3 of cycles 1-5 of mFOLFOX~2. Short course radiation therapy 5 Gy x 5 days~3. Oxaliplatin 85mg/m2 intravenous day 1 of each cycle~4. Leucovorin 400mg/m2 IV Day 1 of each cycle~5. 5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle"

DRUG

mFOLFOX and Radiation Therapy 5Gy x 5 days

"1. Short course radiation therapy 5 Gy x 5 days~2. Oxaliplatin 85mg/m2 intravenous day 1 of each cycle~3. Leucovorin 400mg/m2 IV Day 1 of each cycle~4. 5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle"

Trial Locations (4)

27157

Wake Forest Baptist Health Sciences, Winston-Salem

75390

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas

85724

The University of Arizona Cancer Center, Tucson

97239

Oregon Health & Science University, Portland

All Listed Sponsors
collaborator

Apexigen America, Inc.

INDUSTRY

lead

University of Texas Southwestern Medical Center

OTHER