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.

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05024097
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Etrumadenant (AB928) — DRUG
    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 therapy — RADIATION
    Patients will receive a radiation therapy dose of 25Gy in 5fx
  • FOLFOX regimen — DRUG
    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.
  • Zimberelimab (AB122) — DRUG
    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.

Study Details

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 Dates

Start date
Mar 31, 2022
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation therapy and etrumadenant (AB928)
    Enrolled patients will receive Radiation therapy of 25 Gy in 5 fractions along with etrumadenant 150mg oral drug taken once daily. this will then be followed by 9 cycles of FOLFOX in combination of etrumadenant and zimberelimab investigational drugs.

Primary Outcome Measure

Number of treated patients who achieve complete pathologic response [ Time Frame: Week 24 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brooklyn Methodist Hospital - NewYork PresbyterianNew YorkNew York11215
Mary Palmer, M.S.
[email protected]
Dakota Trick, M.S.
[email protected]
646-962-2196
Hani Ashamalla, M.D. (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital - QueensNew YorkNew York11355
Hina Ali, M.D.
[email protected]
718-670-1541
Dakota Trick, M.S.
[email protected]
646-962-2196
Andrew Brandmaier, M.D. (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10065
Encouse Golden, M.D.,Ph.D.
[email protected]
212-746-3650
Fabiana Gregucci, M.D.
[email protected]
646-962-3110
Encouse Golden, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Brooklyn Methodist Hospital - NewYork Presbyterian· New York, NYNew York Presbyterian Hospital - Queens· New York, NYWeill Cornell Medical College· New York, NY

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