RecruitingPhase 2NCT05024097

A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer.


Sponsor

Weill Medical College of Cornell University

Enrollment

43 participants

Start Date

Mar 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immunotherapy drugs — AB122 (a PD-1 blocker) and AB928 (an adenosine receptor blocker) — given alongside chemotherapy after short-course radiation for rectal cancer that has not yet spread. The goal is to improve outcomes and potentially avoid the need for major surgery. **You may be eligible if...** - You are 18 or older - You have confirmed rectal cancer (adenocarcinoma) - Your tumor is located within 5 cm of the anal opening and can be removed by standard rectal surgery - Your cancer has not spread to distant organs - You have never had prior pelvic radiation or chemotherapy for rectal cancer - Your physical health is good (ECOG score 0–1) **You may NOT be eligible if...** - Your cancer has spread (distant metastases) - You have had prior radiation to the pelvis or prior chemotherapy for rectal cancer - You have active autoimmune disease or are on immunosuppressive therapy - You have significant infections or serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtrumadenant (AB928)

Patients will receive a radiation therapy dose of 25Gy in 5 fractions in combination with etrumadenant 150 mg orally, once daily as part of a continuous dose regimen.

RADIATIONRadiation therapy

Patients will receive a radiation therapy dose of 25Gy in 5fx

DRUGFOLFOX regimen

After completing the radiation therapy, patients will receive FOLFOX regimen for 9 cycles in combination with etrumadenant and zimberelimab. All patients will be offered adjuvant zimberelimab for up to one year.

DRUGZimberelimab (AB122)

After completing the radiation therapy, patients will receive FOLFOX regimen for 9 cycles in combination with etrumadenant and zimberelimab. All patients will be offered adjuvant zimberelimab for up to one year.


Locations(3)

Weill Cornell Medical College

New York, New York, United States

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, United States

New York Presbyterian Hospital - Queens

New York, New York, United States

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NCT05024097


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