Phase I-II Study on the Safety and Effectiveness of PD1 and Adenosine Receptor Blockers with Chemotherapy After Short Radiation for Rectal Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05024097

Provider View

This clinical trial is testing a new treatment approach for rectal cancer that combines short-course radiation with two experimental drugs, AB122 and AB928, followed by chemotherapy. The study aims to determine if this combination is safe and effective in treating rectal cancer.

Patient Parameters

Program Overview

The study involves giving patients a short course of radiation therapy to the pelvic area, along with a daily dose of the drug AB928. This is followed by a chemotherapy regimen called mFOLFOX, combined with AB928 and another drug, AB122, over several weeks. The goal is to see if this treatment can effectively manage rectal cancer. Patients will be monitored through various tests, including physical exams, MRI scans, and endoscopy, to assess how well the treatment is working. A team of specialists will review each case to decide on the next steps, which may include surgery to remove the cancer.

Description

Participants in this study will first receive a short course of radiation therapy aimed at the pelvic area, along with a daily oral dose of the drug AB928. This initial treatment is designed to target the cancer directly. Following this, patients will undergo a series of chemotherapy treatments over several weeks, using a regimen known as mFOLFOX, which is combined with the drugs AB928 and AB122. The purpose of this combination is to enhance the treatment's effectiveness against rectal cancer.

After the chemotherapy phase, patients will be evaluated through a series of tests, including a digital rectal exam, MRI scans of the pelvis, and endoscopy, to determine how well the cancer has responded to the treatment. A multidisciplinary team of experts will review the results to reach a consensus on the treatment's success and decide on further steps, which may include surgical removal of the cancer and affected lymph nodes for further examination.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with rectal adenocarcinoma.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Specific cancer stages (cT3N0 or cT1-3N1) and located within 5cm from the anal verge.
  • Cancer that can be surgically removed.
  • No signs of cancer spread to distant parts of the body.
  • No previous radiation, chemotherapy, or surgery for rectal cancer.
  • No active infections requiring antibiotics.
  • Blood counts and liver function within specified limits.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after.
  • Men must agree to use effective contraception.

Exclusion Criteria

  • Recurrent or primary rectal cancer that cannot be surgically removed.
  • Large lymph nodes or suspected advanced tumor stage.
  • Previous pelvic radiation therapy.
  • Certain heart conditions or medications that interact with study drugs.
  • Gastrointestinal issues that prevent taking oral medications.
  • Previous treatment targeting the adenosine pathway.
  • Severe allergies to similar drugs.
  • Recent history of blood clots or other serious medical conditions.
  • Recent history of other cancers, except for certain skin or cervical cancers.
  • Participation in other cancer treatments or clinical trials.
  • Women who are pregnant or breastfeeding, or not using effective birth control.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.