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NCT06340711
Phase II Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in PD-L1-Negative or Immunotherapy-refractory Esophagogastric Adenocarcinoma
Phase 2 trial testing OBP-301 in Esophageal Adenocarcinoma in 27 participants. Currently enrolling.
1 April 2028
Quick facts
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 25 April 2024 |
| Primary completion | 1 April 2028 |
| Estimated completion | 1 April 2030 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- OBP-301 — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →
- Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
- Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →
Sponsor
Weill Medical College of Cornell University
Who can join
18 and older, any sex, with Esophageal Adenocarcinoma or Gastric Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
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 5.0
Time frame: Until 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 5.0
Time frame: Until 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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06340711
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of OBP-301
Trials testing the same drug.
- NCT04685499 — Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperabl · Phase 2 · terminated
- NCT03172819 — Special Combination of OBP-301 and Pembrolizumab · Phase 1 · completed
- NCT03190824 — Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma · Phase 2 · unknown
Other recruiting trials for Esophageal Adenocarcinoma
Currently open trials in the same condition.
- NCT07392892 — A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer · Phase 2, PHASE3 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT07182149 — A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors · Phase 1 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07021066 — Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors · Phase 1 · recruiting
Other Weill Medical College of Cornell University trials
Trials by the same sponsor.
- NCT07485712 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2 · NA · not yet recruiting
- NCT05811338 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1 · NA · not yet recruiting
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT06818734 — Implementation of a Clinical Decision Support Tool for Postpartum Depression · NA · not yet recruiting
- NCT07485725 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3 · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06340711 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
- Last refreshed: 21 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06340711.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing