Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.

OBP-301 administration on the Day 1, Day 18 and Day 32

OBP-301

Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks

Radiation

Yira Bermudez, PhD, MBA, RAC

This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.

After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety.

This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level.

A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer

A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy

Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy

Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy

Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.

Tumor response as the best overall response of the record within 18 weeks from the start of treatment.

Oncolys BioPharma Inc

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah).

OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.

Telomelysin

Manish Shah, MD

This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease.

This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease. Pembrolizumab has recently received FDA approval for PD-L1 positive gastric and GEJ adenocarcinoma based on the Keynote-059 study. The efficacy of pembrolizumab monotherapy is modest in PD-L1 positive patients (defined as a combined positive score, CPS, of \> 1), with only a \~15% overall response rate. This study will examine the addition of the oncolytic virus, OBP-301, administered prior to pembrolizumab in this patient population. Patients will be enrolled in a two-stage design, with 18 patients in the first stage. All patients will receive OBP-301 at 2x1012 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). All patients treated with OBP-301 will be eligible for the safety cohort.

Primary Endpoints:

* To examine the efficacy of OBP-301 with pembrolizumab in PD-L1 positive advanced gastric and gastroesophageal junction adenocarcinoma in the 3rd or 4th line setting, as assessed by the RECIST response rate.
* To examine the safety of multiple OBP-301 intratumoral injections in combination with pembrolizumab in advanced gastroesophageal adenocarcinoma.

Secondary Endpoint:

• To examine other measures of efficacy of the combination of OBP-301 with pembrolizumab in advanced gastric and esophageal adenocarcinoma including the disease control rate, duration of response, overall survival and progression free survival.

Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

In this aim we will summarize the results from all patient data to assess what are the consistent changes observed in cellular composition in response to immunotherapy and we will investigate how these changes impact response to treatment.

This project will be focused on analyzing the immune landscape of individual tumors from tumor biopsies taken at baseline and on therapy. We will analyze changes associated with relapse and differences between refractory and sensitive patients. Our proposed analysis will take as input somatic mutations, raw WES reads, and raw RNA-Seq reads

This powerful approach will be utilized to characterize tumor immune cell infiltrates at baseline, following the induction of combination therapy and at the time of resection. This will be one of the first longitudinal analyses of tumor immune cell infiltrates by multi-parameter flow cytometry following immunotherapy.

Examination of patients with a partial response or complete response.

Examination of subjects with stable disease, a partial response, or complete response.

Defined as the duration that subjects who have responded to combination therapy remain without disease progression.

Defined as the time from registration to death from any cause.

Defined as the time from registration to cancer progression or death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer	NCT03213054	Esophageal Canc...	OBP-301 Radiation	20 Years - 89 Years	Oncolys BioPharma Inc
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer	NCT03213054	Esophageal Canc...	OBP-301 Radiation	20 Years - 89 Years	Oncolys BioPharma Inc
Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma	NCT03921021	Esophagogastric...	Telomelysin	18 Years -	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for telomelysin

Every month we try and update this database with for telomelysin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for telomelysin

Every month we try and update this database with for telomelysin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for telomelysin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.