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RECRUITING
NCT05024097
PHASE2

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2022-03-31

Completion Date

2030-12

Last Updated

2025-08-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Etrumadenant (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.

RADIATION

Radiation therapy

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

DRUG

FOLFOX 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.

DRUG

Zimberelimab (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