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

NCT06340711 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-06026219
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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

Esophageal Adenocarcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

Pembrolizumab; OBP-301; Immunotherapy

Outcome Measures

Primary Outcomes (3)

• Overall response rate as assessed by the RECIST v1.1

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

  Until disease progression or death, or for a maximum of approximately 2 years

• 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 5.0

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

  Until 90 days after the last dose of study drug

• Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

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

  Until 30 days after the last dose of study drug

Secondary Outcomes (4)

• Disease control rate (DCR)

  Until disease progression or death, for a maximum of approximately 2 years from start of treatment

• Duration of response (DoR)

  Until disease progression or death, or for a maximum of approximately 2 years from start of treatment

• Overall Survival (OS)

  Until death or a maximum of 96 weeks from end of treatment (for a maximum of approximately 4 years from start of treatment)

• Progression free survival (PFS)

  Until disease progression or death, or for a maximum of approximately 2 years from start of treatment

Study Arms (1)

OBP-301 Plus Pembrolizumab

EXPERIMENTAL

All participants will receive 4 intratumoral injections of OBP-301 with each injection occurring approximately 2 weeks apart. All participants will also receive infusions of pembrolizumab every 6 weeks until disease progression or for a maximum of 2 years.

Drug: OBP-301; Drug: Pembrolizumab

Interventions

OBP-301 DRUG

2×10(12) viral particles per injection given intratumorally every 2 weeks for a total of 4 injections starting on Day 1 of the study

Also known as: Suratadenoturev

OBP-301 Plus Pembrolizumab

Pembrolizumab DRUG

400 mg IV given every 6 weeks starting on day 4 of the study and given for up to 2 years

Also known as: Keytruda

OBP-301 Plus Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have clinical or radiographic disease progression on 1L therapy, or within three months of the last dose of immunotherapy
• Patients must be eligible for immunotherapy (i.e. have not had a Grade 3 or 4 immunotherapy related gastrointestinal or pulmonary toxicity, or other immune-related adverse event that excludes them from receiving future immunotherapy per PI discretion)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Merck Sharp & Dohme LLC: collaborator
• Oncolys BioPharma Inc: collaborator

Study Sites (2)

Weill Cornell Medicine/NewYork-Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

pembrolizumab

Study Officials

• Manish Shah, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Owens

CONTACT

646-962-6046; cdo4001@med.cornell.edu

Myriam Elizaire-Williams

CONTACT

mye4001@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)