IRB #

STUDY00020980

Title

Phase II randomized multi-center trial of total neoadjuvant therapy with and without CD40 agonist, APX005M, for locally advanced rectal adenocarcinoma

Principal Investigator

Adel Kardosh

Study Purpose

The purpose of the study is to determine if giving chemoradiation with APX005M, the study drug, before surgery will result in any response in rectal cancer. We are hoping to find out how well this treatment works.

Medical Condition(s)

Rectal cancer
Rectal Adenocarcinoma
Locally Advanced Rectal Cancer
Rectal

Eligibility Criteria

Inclusion:
-At least 18 years of age
-Stage II, III, or IV rectal cancer
- No prior treatment for rectal adenocarcinoma

Exclusion:
-Prior radiation therapy to pelvis
-Any active known or suspected autoimmune disease

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Approximately 3 months of treatment and up to 36 months in follow-up.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

University of Texas Southwestern Medical Center

Recruitment End

02/01/2028

Compensation Provided

No


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