NIH-funded research R01 grant

Early response to radiotherapy and immunotherapy in rectal cancer

Official title: Early response to radiotherapy and immunotherapy in rectal cancer: an integrated molecular, cellular, and spatial approach

Funded at Ut Southwestern Medical Center · NIH-11381119 · Data updated 2026-11-12

A new approach combines short-course radiation, chemotherapy, and an immune therapy antibody to try to shrink rectal cancers before surgery or avoid surgery altogether.

More Immunotherapy research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUt Southwestern Medical Center
NIH-funded
Lab location1 site (Dallas, United States)
Project startAugust 1, 2023
Project endJuly 31, 2028
Funding year2026
Award (this year)$654,115
NIH project number5R01CA283953-04
Project IDNIH-11381119 on NIH RePORTER

Who could benefit from this research

Could help

Adults with locally advanced rectal cancer or those eligible for neoadjuvant therapy in the study framework, particularly those considering non-operative management.

Less likely to help

Patients unlikely to respond to immunotherapy or those with contraindications to radiation, chemotherapy, or theαCD40 antibody may see limited benefit.

What this research studies

This study looks at how rectal cancer tumors respond when radiation, chemotherapy, and an immune-boosting antibody are given together before surgery. It builds on prior work suggesting that adding an αCD40 antibody to standard treatment might enhance anti-tumor immune responses. The research will explore personalization of therapy to increase complete tumor responses and potentially reduce metastatic risk. The team will use human tumor data and relevant models to understand how the combination affects cancer cells and the immune environment. The project includes a phase II trial (INNATE) to test SCRT with CT, with or without sotigolimab, in locally advanced rectal cancer.

Why it matters

Potential benefit: If successful, the approach could increase the chance of durable tumor control and possibly spare some patients from needing major surgery.

How similar studies have gone: Early phase trials have shown some promise for αCD40 antibodies in cancer, but their impact in colorectal cancer remains to be proven.

Where this research is happening

  • Ut Southwestern Medical Center
    Dallas, United States
    Active

Researchers

  • Principal investigator: Aguilera, Todd a — Ut Southwestern Medical Center
  • Study coordinator: Aguilera, Todd a

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.