Actively Recruiting
Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
Led by Weill Medical College of Cornell University · Updated on 2026-04-23
27
Participants Needed
2
Research Sites
309 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer. Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections.
CONDITIONS
Official Title
Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma that can be injected into the tumor (tumor at least 1 cm in size)
- Tumor must be tested for PD-L1 expression using a Combined Positive Score (CPS) with an approved diagnostic test
- If PD-L1 CPS is greater than 1, patient must have received at least one prior systemic therapy including PD-1 or PD-L1 inhibitor
- Patients must have disease progression on first-line therapy or within three months after last immunotherapy dose
- Patients must be eligible for immunotherapy without prior severe immune-related side effects excluding future treatment
- If PD-L1 CPS is less than 1, patient must not have received prior anti-PD-1 or PD-L1 therapy but must have had at least one systemic therapy for advanced disease
You will not qualify if you...
- Currently participating in another investigational study or received investigational therapy within 3 weeks before study start
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapy
- Diagnosis of immunodeficiency or taking systemic steroids over 20 mg/day or other immunosuppressive therapy within 7 days before study
- Known active brain metastases or carcinomatous meningitis
- Recent anti-cancer therapy or radiation within 2 weeks before study start without recovery from side effects
- Another active cancer within 3 years except controlled prostate cancer
- Received live or live-attenuated vaccine within 30 days before first study dose
- Known active hepatitis B, hepatitis C, or HIV infection
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic treatment within 2 weeks before study
- Unable to comply with study procedures
- Previous severe allergic reaction to monoclonal antibodies
- Not recovered from major surgery or has ongoing surgical complications
- History of allogenic tissue or solid organ transplant
- Certain uncontrolled illnesses
- Pregnant, breastfeeding, or planning pregnancy during the study
- Planning to impregnate someone during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
2
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Casey Owens
CONTACT
M
Myriam Elizaire-Williams
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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