OncoMatch/Clinical Trials/NCT05024097
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.
Is NCT05024097 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Etrumadenant (AB928) and FOLFOX regimen for rectal cancer.
Treatment: Etrumadenant (AB928) · FOLFOX regimen · Zimberelimab (AB122) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage CT3N0, CT1-3N1, CN2 (clinical TNM)
cT3N0 or cT1-3N1 or cT4 or cN2
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: pelvic radiation therapy
No prior pelvic radiation therapy
Cannot have received: chemotherapy
No prior chemotherapy or surgery for rectal cancer
Cannot have received: surgery
No prior chemotherapy or surgery for rectal cancer
Cannot have received: agent targeting the adenosine pathway
Prior treatment with an agent targeting the adenosine pathway
Cannot have received: allogenic stem cell or solid organ transplantation
Patients with prior allogenic stem cell or solid organ transplantation
Lab requirements
Blood counts
Hgb >8.0 gm/dL, PLT > 150,000/mm3
Kidney function
Serum creatinine level ≤ 1.5x the upper limit of normal
Liver function
total bilirubin ≤ 1.5x upper limit of normal, AST ≤ upper limit of normal, ALT ≤ 3x upper limit of normal
Cardiac function
QTc < 480 msec using Fredericia's QT correction formula
Hgb >8.0 gm/dL, PLT > 150,000/mm3, total bilirubin ≤ 1.5x upper limit of normal, AST ≤ upper limit of normal, ALT ≤ 3x upper limit of normal; Serum creatinine level ≤1.5x the upper limit of normal; QTc ≥480 msec using Fredericia's QT correction formula [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Weill Cornell Medical College · New York, New York
- Brooklyn Methodist Hospital - NewYork Presbyterian · New York, New York
- New York Presbyterian Hospital - Queens · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05024097 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CT3N0 or CT1-3N1 or CN2 is required.
Is there an age limit?
Yes. Patients must be 90 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages