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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06340711
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 25, 2024
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/NewYork-Presbyterian HospitalNew YorkNew York10065
Manish Shah, M.D. (PRINCIPAL_INVESTIGATOR)
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Jennifer Eads, MD
[email protected]
215-662-3141

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By research site
Weill Cornell Medicine/NewYork-Presbyterian Hospital· New York, NYAbramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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