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Study of OBP-301 with Pembrolizumab for Esophagogastric Adenocarcinoma

This study is testing a combination of two drugs, OBP-301 and pembrolizumab, for advanced or metastatic stomach (gastric), esophageal, or gastroesophageal junction adenocarcinoma. OBP-301 is injected directly into the tumor, and pembrolizumab is given through an IV. Researchers want to see if this combination is safe and effective, especially for patients whose cancer has progressed after prior immunotherapy. To join, you must have advanced or metastatic cancer that can be injected, and your tumor must be tested for a biomarker called PD-L1. The study aims to see if at least 20% of participants respond to the treatment. The study plans to enroll 27 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a Phase II study, which typically evaluates effectiveness and safety in a larger group of people.
What's involved
You would receive OBP-301 injections into your tumor every two weeks for a total of four injections, and pembrolizumab infusions every six weeks for up to two years or until your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track serious side effects for up to 90 days after your last dose and other side effects for up to 30 days after your last dose. They will also assess your overall response to treatment until disease progression or death, or for a maximum of approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06340711

Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~27 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:OBP-301Pembrolizumab

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate as assessed by the RECIST v1.1
Measured over Until disease progression or death, or for a maximum of approximately 2 years
+2 more outcomes measured

Conditions

Esophageal Adenocarcinoma
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT06340711

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Weill Cornell Medicine/NewYork-Presbyterian Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Manish Shah, M.D. · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Casey Owens
[email protected]
646-962-6046
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma amenable to intra-tumoral injection (i.e. at least 1 cm in size)
Tumor must be examined forPD-L1 assessment as defined by a Combined Positive Score (CPS), and approved commercial diagnostic assay
If the PD-L1 CPS score is \> 1, patients must have received at least one line of systemic therapy for advanced disease that includes a PD-1 or PD-L1 inhibitor.
If the PD-L1 CPS score is \< 1, patients must not have received prior anti-PD-1 or PD-L1 therapy and must have received at least one line of systemic therapy for advanced disease.

Exclusion

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 3 weeks of study Day 1.
Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than equivalent of 20 mg/day) or any other form of immunosuppressive therapy within 7 days prior to study Day 1.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has had prior anti-cancer monoclonal antibody chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, who has not recovered from adverse events due to a previously administered agent.
Has a known additional malignancy within 3 years before the first OBP-301 administration that is progressing or requires active treatment, with the exception of prostate cancer controlled with androgen deprivation therapy.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Is known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy within 2 weeks of Day 1.
Is unable to comply with protocol procedures
Previous severe hypersensitivity (≥ Grade 3) to any monoclonal antibody
Has not adequately recovered from major surgery or has ongoing surgical complications.
Has had an allogenic tissue/solid organ transplant
Has certain uncontrolled illnesses
Is pregnant or breastfeeding or planning to become pregnant or start breast feeding during the study time period
Is expecting to get someone else pregnant during the study time period

What this trial measures

  • Overall response rate as assessed by the RECIST v1.1Until disease progression or death, or for a maximum of approximately 2 years

    Overall response is defined as the sum of partial responses plus complete responses as defined by RECIST v1.1 criteria.

  • Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0Until 90 days after the last dose of study drug

    All SAEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs

  • Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0Until 30 days after the last dose of study drug

    All AEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs