Recruiting
Phase 2

Telomelysin & Pembrolizumab

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06340711

Conditions

Esophageal Adenocarcinoma

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OBP-301

Pembrolizumab

Study Details

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

Study ID

NCT06340711

Start date

Apr 25, 2024

Status verified date

Apr, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

1. Patients must have clinical or radiographic disease progression on 1L therapy, or within three months of the last dose of immunotherapy
2. 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.

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

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OBP-301 Plus Pembrolizumab

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.

Interventions

OBP-301

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

Pembrolizumab

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

Primary outcome measure

  • Overall response rate as assessed by the RECIST v1.1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Until 30 days after the last dose of study drug ]

Central Contacts and Locations

Central contacts

Casey Owens

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

Myriam Elizaire-Williams

mye4001@med.cornell.edu

Locations

Weill Cornell Medicine/NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Casey Owens

cdo4001@med.cornell.edu

Principal Investigator:

Manish Shah, M.D.

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jennifer Eads, MD

215-662-3141jennifer.eads@pennmedicine.upenn.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Pembrolizumab
  • OBP-301
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-04-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.