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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with advanced or metastatic esophageal and gastric cancer, specifically using a research drug called Suratadenoturev (OBP-301) alongside pembrolizumab. The main aim is to find out if this combination is safe and effective. Participants will receive five injections of OBP-301 directly into their tumors over a period of about ten weeks, while also receiving pembrolizumab infusions every six weeks for up to two years or until their cancer worsens.

To be eligible for this trial, participants need to have a specific type of cancer that is advanced and can be injected directly, with tumors that are at least 1 cm in size. They must also have tumors that test positive for PD-L1 and negative for HER2. Participants should expect regular visits for their injections and infusions, as well as some tests to monitor their health. It's important to note that there are certain medical conditions and treatments that may exclude someone from participating, such as recent cancer therapies or active autoimmune diseases. Overall, this trial offers a potential new option for patients seeking treatment for their cancer.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 PD-L1 positive as defined by a combined positive score (CPS), i.e. CPS ≥ 1 by approved, commercial diagnostic assay
• • Tumor must be HER2 negative as determined by a CLIA-approved laboratory
• Exclusion Criteria:
• • 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