Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04641871
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2020-10-29
Brief Title:
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies
Sponsor:
Symphogen AS
Organization:
Symphogen AS
Study Overview
Official Title:
An Exploratory Open-label Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 Anti-PD 1 in Combination With Either Sym022 Anti-LAG-3 or Sym023 Anti-TIM-3 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies
Status:
COMPLETED
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:
The study will evaluate the preliminary efficacy of 3 combinations Sym021Sym022 Sym021Sym023 and Sym021Sym023irinotecan in patients with biliary tract carcinomas BTC and with esophageal squamous cell carcinoma ESCC by assessing overall response rates ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumors RECIST v11 The study will also evaluate the safety and tolerability profile of the 3 combinations
Detailed Description:
The study will evaluate safety and efficacy in patients with
Biliary tract carcinomas patients who have progressed on one prior line of gemcitabine and platinum-based chemotherapy in the metastatic setting
Esophageal squamous cell carcinoma patients who have progressed on one prior line of platinum-based chemotherapy in the metastatic setting
The trial is set up as 3 sub-studies
Sub-study 1 includes biliary tract carcinoma patients and is composed of 2 investigational combination treatment arms Sym021Sym022 Arm A and Sym021Sym023 Arm B
Sub-study 2 includes biliary tract carcinoma patients and is composed of one investigational combination treatment armSym021Sym023irinotecan A safety lead- in phase is included to assess tolerability of the combination A Study Safety Team will review clinical and laboratory safety data and will make decisions regarding the continued enrollment after the safety lead-in phase
Sub-Study 3 includes esophageal squamous cell carcinoma patients and is composed of one investigational combination treatment arm Sym021Sym023irinotecan Dose of irinotecan in this arm will be selected based upon the safety lead in in sub-study 2 period
August 2021 Based upon results from a recent per protocol Interim Analysis IA it is has been decided as of 3rd of August 2021 to stop further enrollment into Sub-study 1 Arm A Sym021Sym022 Future patients will be allocated to either Sub-study 1 Arm B Sym021Sym023 or Sub-study 2 Sym021Sym023irinotecan
Biliary tract carcinomas patients who have progressed on one prior line of gemcitabine and platinum-based chemotherapy in the metastatic setting
Esophageal squamous cell carcinoma patients who have progressed on one prior line of platinum-based chemotherapy in the metastatic setting
The trial is set up as 3 sub-studies
Sub-study 1 includes biliary tract carcinoma patients and is composed of 2 investigational combination treatment arms Sym021Sym022 Arm A and Sym021Sym023 Arm B
Sub-study 2 includes biliary tract carcinoma patients and is composed of one investigational combination treatment armSym021Sym023irinotecan A safety lead- in phase is included to assess tolerability of the combination A Study Safety Team will review clinical and laboratory safety data and will make decisions regarding the continued enrollment after the safety lead-in phase
Sub-Study 3 includes esophageal squamous cell carcinoma patients and is composed of one investigational combination treatment arm Sym021Sym023irinotecan Dose of irinotecan in this arm will be selected based upon the safety lead in in sub-study 2 period
August 2021 Based upon results from a recent per protocol Interim Analysis IA it is has been decided as of 3rd of August 2021 to stop further enrollment into Sub-study 1 Arm A Sym021Sym022 Future patients will be allocated to either Sub-study 1 Arm B Sym021Sym023 or Sub-study 2 Sym021Sym023irinotecan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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