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.

PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2030

Conditions
Rectal Cancer
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.

Trial Locations (3)

10065

RECRUITING

Weill Cornell Medical College, New York

11215

RECRUITING

Brooklyn Methodist Hospital - NewYork Presbyterian, New York

11355

RECRUITING

New York Presbyterian Hospital - Queens, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Arcus Biosciences, Inc.

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER