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INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

NCT04130854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-06

No results posted yet for this study

Summary

Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

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

Sponsors & Collaborators

  • Apexigen America, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Todd Aguilera, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2026-01-30
Completion
2026-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04130854 on ClinicalTrials.gov