Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490198
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-30
Brief Title:
Phase 2 Study OBI-833OBI-821 Maintenance for Globo H Advanced Biliary Tract Cancer After GemcitabineCisplatin
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
A Single-Arm Phase 2 Study to Evaluate OBI-833OBI-821 Maintenance Therapy in Patients With Globo H-Positive Advanced Biliary Tract Cancer Not Progresseding Under First-Line Gemcitabine and Cisplatin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2 clinical trial protocol for evaluating the efficacy and safety of OBI-833OBI-821 a carbohydrate-conjugate vaccine combined with an immune adjuvant as maintenance therapy in combination with first-line gemcitabine and cisplatin chemotherapy for patients with Globo H-positive advanced biliary tract cancer The study is designed as a single-arm trial with 30 patients who have achieved stable disease partial response or complete response after 31 months of initial chemotherapy The primary endpoint is progression-free survival with secondary endpoints including overall survival tumor response and safety profile The treatment regimen involves subcutaneous injections of OBI-833OBI-821 on a gradually decreasing frequency schedule for up to 80 weeks The trial also includes exploratory objectives to assess immune responses and biomarkers This study aims to address the unmet need for improved treatment options in advanced biliary tract cancer by leveraging the potential of immunotherapy targeting the Globo H antigen
Detailed Description:
This clinical trial is a single-arm phase 2 study evaluating OBI-833OBI-821 as maintenance therapy in patients with Globo H-positive advanced biliary tract cancer who have not progressed on first-line gemcitabine and cisplatin chemotherapy The study is grounded in the challenging prognosis of biliary tract cancer including cholangiocarcinoma which has limited treatment options Currently the standard first-line therapy is gemcitabine plus cisplatin but progression-free survival remains short at around 6 months highlighting the need for improved treatment strategies
The investigational therapy OBI-833 is a glycoconjugate vaccine targeting Globo H a tumor-associated carbohydrate antigen expressed in many epithelial cancers It is used in combination with OBI-821 an adjuvant designed to enhance the immune response Previous studies have demonstrated that OBI-833OBI-821 can elicit immune responses and provide disease stabilization in some cancer patients Notably Globo H expression has been detected in about 41 of intrahepatic cholangiocarcinoma specimens providing a rationale for investigating this approach in biliary tract cancer
The study design involves enrolling 30 patients in a single-arm trial Eligible patients must have Globo H-positive advanced biliary tract cancer that has not progressed after 31 months of first-line gemcitabinecisplatin therapy Patients will receive OBI-833OBI-821 subcutaneously on a gradually decreasing frequency schedule for up to 80 weeks while continuing their gemcitabinecisplatin regimen The primary endpoint of the study is progression-free survival with secondary endpoints including overall survival tumor response safety and correlations between Globo H expressionantibodies and survival outcomes
To ensure safety the study incorporates a lead-in safety cohort of 6 patients before proceeding to full enrollment Following the treatment period patients will be followed for survival for up to 12 months after the end of treatment This single-arm design allows for an efficient assessment of efficacy signals that could inform potential further development of this therapeutic approach
The overall aim of the study is to evaluate whether adding OBI-833OBI-821 maintenance therapy can prolong disease control in this patient population with high unmet medical need By focusing on patients with Globo H-positive tumors who have initially responded to standard chemotherapy the study seeks to explore a potentially targeted approach to maintaining and extending the benefits of first-line treatment in advanced biliary tract cancer
The investigational therapy OBI-833 is a glycoconjugate vaccine targeting Globo H a tumor-associated carbohydrate antigen expressed in many epithelial cancers It is used in combination with OBI-821 an adjuvant designed to enhance the immune response Previous studies have demonstrated that OBI-833OBI-821 can elicit immune responses and provide disease stabilization in some cancer patients Notably Globo H expression has been detected in about 41 of intrahepatic cholangiocarcinoma specimens providing a rationale for investigating this approach in biliary tract cancer
The study design involves enrolling 30 patients in a single-arm trial Eligible patients must have Globo H-positive advanced biliary tract cancer that has not progressed after 31 months of first-line gemcitabinecisplatin therapy Patients will receive OBI-833OBI-821 subcutaneously on a gradually decreasing frequency schedule for up to 80 weeks while continuing their gemcitabinecisplatin regimen The primary endpoint of the study is progression-free survival with secondary endpoints including overall survival tumor response safety and correlations between Globo H expressionantibodies and survival outcomes
To ensure safety the study incorporates a lead-in safety cohort of 6 patients before proceeding to full enrollment Following the treatment period patients will be followed for survival for up to 12 months after the end of treatment This single-arm design allows for an efficient assessment of efficacy signals that could inform potential further development of this therapeutic approach
The overall aim of the study is to evaluate whether adding OBI-833OBI-821 maintenance therapy can prolong disease control in this patient population with high unmet medical need By focusing on patients with Globo H-positive tumors who have initially responded to standard chemotherapy the study seeks to explore a potentially targeted approach to maintaining and extending the benefits of first-line treatment in advanced biliary tract cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None