NCT04130854

INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial With and Without APX005M, an Anti-CD40 Agonist

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A phase II randomized trial 3:2 with short course radiotherapy followed by mFOLFOX chemotherapy prior to trans abdominal resection with or without an antiCD40 agonist antibody (APX005M). There will be continuous safety assessment for at least 6 patients. Planned accrual of 58 patients. An interim analysis after 30 patients have completed treatment and there will be early stopping criteria for futility or efficacy. Short course radiotherapy will consist of 5Gy x 5 to the pelvis and patients on APX005M arm will receive one infusion during radiotherapy course, have a two week break, then start FOLFOX with APX005M in conjunction with five out of six cycles of chemotherapy. Patients will be restaged and then undergo definitive surgery.

Conditions

• Locally Advanced Rectal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-24
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2019-10-18
• Last updated: 2026-01-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study