Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02915432
Status:
UNKNOWN
Last Update Posted:
2021-12-13
First Post:
2016-09-21
Brief Title:
The Study to Evaluate Toripalimab JS001 in Patients With Advanced GC ESCC NPC HNSCC
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Multi-Center Open Label Phase IbII Clinical Study to Evaluate JS001 in Patients With Advanced Gastric Adenocarcinoma Esophageal Squamous Cell Carcinoma Nasopharyngeal Carcinoma and Head and Neck Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Infusion JS001 in treating advanced gastric adenocarcinoma esophageal squamous cell carcinoma nasopharyngeal carcinoma and head and neck squamous cell carcinoma and to determine the recommended phase II dose RP2D
Detailed Description:
Overall Design
This is a multicenter open-label phase IbII clinical study of Toripalimab Injection JS001 in patients with gastric adenocarcinoma GC esophageal squamous cell carcinoma ESCC nasopharyngeal carcinoma NPC or head and neck squamous cell carcinoma HNSCC On the basis of the results of safety and pharmacokinetic data in the phase I study of JS001 3 mgkg is determined as the recommended dose of the 2-week monotherapy regimen and no study on the 10 mgkg cohorts will be conducted any more And the corresponding 240 mg and 360 mg are determined as the corresponding exploratory doses of the 3-week combined treatment regimens
Eligible subjects will be selected based on the inclusion and exclusion criteria subjects with gastric adenocarcinoma esophageal squamous cell carcinoma nasopharyngeal carcinoma or head and neck squamous cell carcinoma cohort 1 2 3 4 respectively will receive treatment at the dose of 3 mgkg While subjects with advanced gastric adenocarcinoma esophageal squamous cell carcinoma nasopharyngeal carcinoma or head and neck squamous cell carcinoma cohort 5 6 7 8 respectively who have not received any treatment before will be treated with the corresponding 3-week regimen of standard first-line chemotherapy combined with JS001 240 mg or 360 mg
Study Treatment
The study on the 3 mgkg cohorts is planned to be conducted first in cohort 1 2 3 4 in this trial After enrollment the subjects will receive study treatment once every 2 weeks Q2W with 4 weeks as a cycle until absence of further benefits judged by the investigator disease progression occurrence of intolerable toxicity investigators decision withdrawal of informed consent by the subject or death
The study of cohort 5 6 7 and 8 will be carried out in the sites designated by the sponsor Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 240 mg or 360 mg once every 3 weeks Q3W see Section 31 Overall Design for details JS001 240 mg or 360 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator disease progression occurrence of intolerable toxicity investigators decision and withdrawal of informed consent by the subject or death
If the subject experiences disease progression but the subject can still obtain clinical benefit from the study treatment of JS001 according to the investigator the subject can continue the study treatment if an approval is obtained after discussion between the investigator and the medical monitor from the sponsor or the authorized CRO If the subject develops disease progression for a second time heshe should permanently withdraw from the study treatment
Tumor Assessment
During the study for cohort 1 2 3 and 4 tumor responses will be evaluated every 8 weeks in the first year according to RECIST 11 and every 12 weeks thereafter Tumor responses will also be evaluated according to irRECIST at the same frequency with that conducted according to RECIST 11 until disease progression death or loss of follow up whichever comes first For cohort 5 6 7 and 8 tumor responses will be evaluated every 6 weeks 3 days in the first year according to RECIST 11 and irRECIST and every 12 weeks thereafter until disease progression death or loss of follow up whichever comes first
The radiographic data of the subjects will be collected for review by IRC The IRC will evaluate the corresponding study endpoints based on tumor responses but no such evaluation is planned for cohort 5 6 7 and 8
Pharmacokinetics
At least 10 of the subjects no requirements on indications in JS001 3 mgkg cohorts at the sponsor-designated study sites should complete the pharmacokinetic blood sampling in the first 3 cycles of study treatment until 60 days after the end of study treatment If a subject did not complete the scheduled sample collection in the first 3 cycles of study treatment due to any reason another subject should be added
Corresponding pharmacokinetic blood samplings will also be conducted for cohort 5 6 7 and 8 to evaluate the pharmacokinetic characteristics of JS001 used in the combined treatment with chemotherapy At least 3 patients will be selected for blood sampling in each cohort
Acquisition of Tumor Tissue Specimens
Subjects with esophageal squamous cell carcinoma gastric adenocarcinoma including adenocarcinoma at esophageal-gastric conjunction nasopharyngeal carcinoma or head and neck squamous cell carcinoma must provide acceptable tumor tissue specimens fresh tumor tissue specimens for biopsy before enrollment are preferred prior to enrollment for future use in subsequent exploratory studies
Any subject with the response confirmed as partial response PR andor progressive disease PD is encouraged to voluntarily participate in the selectable biomarkers study if tumor tissues can be obtained from himher And in the selectable biomarkers study they will provide tumor tissues for exploratory study on the correlation between tumor markers and the level of anti-tumor responses
All the tumor tissue specimens provided will be sent to the designated central laboratory for evaluation
End of Study
The primary endpoint of the study is ORR The study will be completed at 12 months after the last patient in and data analysis will be conducted then If by that time there are still some subjects receiving study treatment these subjects will be transferred to an extension study to continue the study treatment until absence of further benefits judged by investigator disease progression occurrence of intolerable toxicity investigators decision withdrawal of informed consent by subject or death
This is a multicenter open-label phase IbII clinical study of Toripalimab Injection JS001 in patients with gastric adenocarcinoma GC esophageal squamous cell carcinoma ESCC nasopharyngeal carcinoma NPC or head and neck squamous cell carcinoma HNSCC On the basis of the results of safety and pharmacokinetic data in the phase I study of JS001 3 mgkg is determined as the recommended dose of the 2-week monotherapy regimen and no study on the 10 mgkg cohorts will be conducted any more And the corresponding 240 mg and 360 mg are determined as the corresponding exploratory doses of the 3-week combined treatment regimens
Eligible subjects will be selected based on the inclusion and exclusion criteria subjects with gastric adenocarcinoma esophageal squamous cell carcinoma nasopharyngeal carcinoma or head and neck squamous cell carcinoma cohort 1 2 3 4 respectively will receive treatment at the dose of 3 mgkg While subjects with advanced gastric adenocarcinoma esophageal squamous cell carcinoma nasopharyngeal carcinoma or head and neck squamous cell carcinoma cohort 5 6 7 8 respectively who have not received any treatment before will be treated with the corresponding 3-week regimen of standard first-line chemotherapy combined with JS001 240 mg or 360 mg
Study Treatment
The study on the 3 mgkg cohorts is planned to be conducted first in cohort 1 2 3 4 in this trial After enrollment the subjects will receive study treatment once every 2 weeks Q2W with 4 weeks as a cycle until absence of further benefits judged by the investigator disease progression occurrence of intolerable toxicity investigators decision withdrawal of informed consent by the subject or death
The study of cohort 5 6 7 and 8 will be carried out in the sites designated by the sponsor Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 240 mg or 360 mg once every 3 weeks Q3W see Section 31 Overall Design for details JS001 240 mg or 360 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator disease progression occurrence of intolerable toxicity investigators decision and withdrawal of informed consent by the subject or death
If the subject experiences disease progression but the subject can still obtain clinical benefit from the study treatment of JS001 according to the investigator the subject can continue the study treatment if an approval is obtained after discussion between the investigator and the medical monitor from the sponsor or the authorized CRO If the subject develops disease progression for a second time heshe should permanently withdraw from the study treatment
Tumor Assessment
During the study for cohort 1 2 3 and 4 tumor responses will be evaluated every 8 weeks in the first year according to RECIST 11 and every 12 weeks thereafter Tumor responses will also be evaluated according to irRECIST at the same frequency with that conducted according to RECIST 11 until disease progression death or loss of follow up whichever comes first For cohort 5 6 7 and 8 tumor responses will be evaluated every 6 weeks 3 days in the first year according to RECIST 11 and irRECIST and every 12 weeks thereafter until disease progression death or loss of follow up whichever comes first
The radiographic data of the subjects will be collected for review by IRC The IRC will evaluate the corresponding study endpoints based on tumor responses but no such evaluation is planned for cohort 5 6 7 and 8
Pharmacokinetics
At least 10 of the subjects no requirements on indications in JS001 3 mgkg cohorts at the sponsor-designated study sites should complete the pharmacokinetic blood sampling in the first 3 cycles of study treatment until 60 days after the end of study treatment If a subject did not complete the scheduled sample collection in the first 3 cycles of study treatment due to any reason another subject should be added
Corresponding pharmacokinetic blood samplings will also be conducted for cohort 5 6 7 and 8 to evaluate the pharmacokinetic characteristics of JS001 used in the combined treatment with chemotherapy At least 3 patients will be selected for blood sampling in each cohort
Acquisition of Tumor Tissue Specimens
Subjects with esophageal squamous cell carcinoma gastric adenocarcinoma including adenocarcinoma at esophageal-gastric conjunction nasopharyngeal carcinoma or head and neck squamous cell carcinoma must provide acceptable tumor tissue specimens fresh tumor tissue specimens for biopsy before enrollment are preferred prior to enrollment for future use in subsequent exploratory studies
Any subject with the response confirmed as partial response PR andor progressive disease PD is encouraged to voluntarily participate in the selectable biomarkers study if tumor tissues can be obtained from himher And in the selectable biomarkers study they will provide tumor tissues for exploratory study on the correlation between tumor markers and the level of anti-tumor responses
All the tumor tissue specimens provided will be sent to the designated central laboratory for evaluation
End of Study
The primary endpoint of the study is ORR The study will be completed at 12 months after the last patient in and data analysis will be conducted then If by that time there are still some subjects receiving study treatment these subjects will be transferred to an extension study to continue the study treatment until absence of further benefits judged by investigator disease progression occurrence of intolerable toxicity investigators decision withdrawal of informed consent by subject or death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None