Actively Recruiting
Phase II Study of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy Following Short-Course Radiation for Rectal Cancer
Led by Weill Medical College of Cornell University ยท Updated on 2025-08-27
43
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
A
Arcus Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of combining two investigational drugs, PD1 antagonist AB122 and adenosine receptor antagonist AB928, with chemotherapy and short-course radiation therapy in patients with rectal cancer. The study focuses on those with certain stages of rectal adenocarcinoma who have not received prior pelvic radiation or chemotherapy. It is a Phase II trial conducted by Weill Medical College of Cornell University to assess treatment outcomes and side effects. Patients will first receive short-course radiation therapy (25 Gy in 5 fractions) to the pelvic tumor during the first week, alongside daily oral doses of AB928 (150 mg). Following this, from weeks 3 to 20, they will undergo consolidation chemotherapy with the mFOLFOX regimen for nine cycles, combined with both AB928 and AB122. After chemotherapy, participants may receive additional adjuvant AB122 for up to one year. Treatment response will be evaluated before surgery. Participants will be assessed between weeks 22 and 24 using physical exam, pelvic MRI, and endoscopy to determine tumor response. A specialized tumor board will review each case to reach a consensus. At week 24, patients will undergo total mesorectal excision surgery for detailed pathological examination of the tumor and lymph nodes. Researchers will monitor treatment responses, side effects at multiple time points, progression-free survival up to 36 months, and overall survival up to 60 months.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the rectum
- Age 18 to 90 years
- ECOG performance status 0-1
- Clinical staging cT3N0 or cT1-3N1 or cT4 or cN2
- Tumor located within 5 cm from the anal verge
- Rectal cancer suitable for total mesorectal excision
- No distant metastases present
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No active infections requiring systemic antibiotics
- Hemoglobin greater than 8.0 gm/dL
- Platelet count above 150,000/mm3
- Total bilirubin at or below 1.5 times upper limit of normal
- AST within normal limits
- ALT at or below 3 times upper limit of normal
- Ability to read, understand, and sign informed consent (with translator if needed)
- Negative pregnancy test within 4 weeks before starting treatment for females of reproductive potential
- Use of effective contraception for males and females with reproductive potential during and after treatment as specified
- Agreement to use reliable contraception throughout the study period
You will not qualify if you...
- Recurrent rectal cancer
- Primary rectal tumor deemed unresectable or adherent to adjacent pelvic structures
- Involved radial surgical margin
- Serum creatinine above 1.5 times upper limit of normal
- Prior pelvic radiotherapy
- QTc interval 480 msec or greater
- Recent use of certain oral drugs affecting drug metabolism or transport within 4 weeks prior to treatment
- Use of herbal or natural remedies, including cannabinoids unless approved
- Gastrointestinal conditions preventing oral medication use
- Prior treatment targeting the adenosine pathway
- Prior allogeneic stem cell or solid organ transplant
- Active or recent autoimmune disease requiring systemic treatment except specified exceptions
- History of idiopathic pulmonary fibrosis, pneumonitis, or interstitial lung disease
- Recent systemic immunosuppressive medication use exceeding specified doses
- Live vaccine within 30 days prior to treatment
- Known dihydropyrimidine dehydrogenase deficiency
- Grade 2 or higher peripheral neuropathy
- Severe allergic reactions to antibodies or fusion proteins
- Arterial thrombotic events within past 6 months
- Other medical or psychiatric conditions judged unsuitable by investigator
- Prior malignancy within 5 years except treated skin or cervical cancer
- Recent thrombotic episodes unless on stable anticoagulant therapy
- Concurrent anticancer or experimental therapies
- Pregnancy or breastfeeding, or unwillingness to use birth control for women of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive short-course pelvic radiation therapy over one week combined with daily oral etrumadenant.
5 visits (in-person) during radiation therapy
Duration - Approximately 18 weeks
Participants receive 9 cycles of mFOLFOX chemotherapy combined with daily oral etrumadenant and zimberelimab.
Weekly visits during chemotherapy cycles
Duration - 2 to 3 weeks
Participants undergo assessment of treatment response using digital rectal examination, pelvic MRI, and endoscopy reviewed by a multidisciplinary tumor board.
1 to 2 visits for assessments
Duration - 1 day
Participants undergo total mesorectal excision surgery for pathologic evaluation of the tumor and pelvic lymph nodes.
1 surgical procedure
Trial Site Locations
Total: 3 locations
1
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
2
Brooklyn Methodist Hospital - NewYork Presbyterian
New York, New York, United States, 11215
Actively Recruiting
3
New York Presbyterian Hospital - Queens
New York, New York, United States, 11355
Actively Recruiting
Research Team
F
Fabiana Gregucci, M.D.
D
Dakota Trick, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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