Esophageal Cancer Clinical Trial
Official title:
A Phase 2 Study of APX005M in Combination With Concurrent Chemoradiation as Neoadjuvant Therapy for Resectable Esophageal and Gastroesophageal Junction Cancers
Verified date | December 2023 |
Source | Apexigen America, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot phase II trial studies the side effects of CD40 agonistic monoclonal antibody APX005M (APX005M), chemotherapy, and radiation therapy, and to see how well they work when given before surgery in treating patients with esophageal cancer or gastroesophageal cancer that can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Status | Completed |
Enrollment | 34 |
Est. completion date | February 21, 2023 |
Est. primary completion date | November 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years of age 2. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction 3. Surgically resectable (T1-3 Nx preferably by endoscopic ultrasound [EUS]). (Excluded: T1N0 tumors, cervical esophageal location, tumors invading the tracheobronchial tree or with fistula, distant disease that cannot be included in the radiation field or be resected at the time of esophagectomy) 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Adequate hematological, renal, and hepatic parameters Exclusion Criteria: 1. Any history of or current hematologic malignancy 2. History of a second primary cancer is allowed in the event the cancer is curatively resected and there is no evidence of recurrence/metastatic disease x 1 year. Subjects who have a history of cervical or breast carcinoma in situ, localized prostate cancer, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors [Ta, Tis & T1] are also allowed. 3. Major surgery within 4 weeks of first dose of investigational product 4. Prior or concurrent treatment with any anticancer agent for the same cancer diagnosis 5. Prior exposure to any immuno-oncology agents, including CD40/PD-1/PD-L1/CTLA-4 inhibitors (if any ambiguity, should be discussed with study principal investigator) 6. History of bone marrow transplantation 7. History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders 8. Chronic steroid dependency (prednisone equivalent > 10 mg/day). Any steroid use should be discontinued at least 2 weeks prior to initiation of study treatment. 9. Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose 10. Known human immunodeficiency virus (HIV) infection |
Country | Name | City | State |
---|---|---|---|
United States | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | New York University | New York | New York |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington | Seattle | Washington |
United States | Renovatio Clinical | The Woodlands | Texas |
United States | University of Arizona | Tucson | Arizona |
United States | MedStar Georgetown University Hospital (MGUH) | Washington | District of Columbia |
United States | Wake Forest School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Apexigen America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic complete response (pCR) rate | At time of surgery (at 10-16 weeks) | ||
Secondary | Rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery) | At time of surgery | ||
Secondary | Pathologic stage at time of surgery | At time of surgery | ||
Secondary | Radiographic/metabolic response to neoadjuvant treatment on Computed Tomography (CT) / CT-Positron Emission Tomography (PET) (CT-PET) | Baseline, then at time of surgery, and 3 and 6 months post-operatively | ||
Secondary | Frequency of adverse events | Up to 5 months for each patient |
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