Actively Recruiting
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.
Led by Weill Medical College of Cornell University · Updated on 2025-08-27
43
Participants Needed
3
Research Sites
452 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
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.
CONDITIONS
Official 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 diagnosis of adenocarcinoma of the rectum
- Age 18 years or older
- ECOG performance status 0-1
- Tumor stage cT3N0, cT1-3N1, cT4, or cN2
- Tumor located 5cm from the anal verge
- Rectal cancer suitable for total mesorectal excision
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No infections requiring systemic antibiotics
- Hemoglobin above 8.0 gm/dL, platelet count above 150,000/mm3
- Total bilirubin no more than 1.5 times upper limit of normal
- AST no more than upper limit of normal
- ALT no more than 3 times upper limit of normal
- Ability to read, understand, and sign informed consent
- Female participants of reproductive potential must have negative pregnancy test within 4 weeks before treatment
- Female and male participants must agree to use effective contraception during and after study treatment as specified
- Women not surgically sterilized and between menarche and 1 year post menopause must meet pregnancy testing and contraception requirements
You will not qualify if you...
- Recurrent rectal cancer
- Primary unresectable rectal cancer with involvement of adjacent structures
- Involved radial margin
- Serum creatinine more than 1.5 times upper limit of normal
- Prior pelvic radiotherapy
- QTc interval 480 msec or longer
- Recent treatment with certain drugs that interact with etrumadenant
- Use of herbal or natural remedies containing cannabinoids unless approved
- Gastrointestinal conditions preventing oral medication use
- Prior treatment targeting the adenosine pathway
- Prior allogenic stem cell or solid organ transplant
- Active or recent autoimmune disease requiring systemic treatment except vitiligo or resolved childhood asthma/atopy
- History of idiopathic pulmonary fibrosis, pneumonitis, or interstitial lung disease
- Recent treatment with systemic immunosuppressive medication above specified doses
- Live vaccine within 30 days prior
- Known dihydropyrimidine dehydrogenase deficiency
- Peripheral neuropathy Grade 2 or higher
- History of severe allergic reactions to antibodies or fusion proteins
- Arterial thrombotic event within past 6 months
- Other medical or psychiatric conditions making participation inappropriate
- Prior malignancy within 5 years except treated skin or cervical cancers
- History of thrombotic episodes more than 6 months prior but stable on anticoagulants
- Receiving other anticancer or experimental therapies
- Pregnant or breastfeeding women or unwilling/unable to use birth control as required
AI-Screening
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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.
CONTACT
D
Dakota Trick, M.S.
CONTACT
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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