Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649331
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast CancerA Prospective Open-label Multicenter Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective open-label multicenter phase II platform trial The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs ADCs in patients with advanced breast cancer who had previously used antibody-conjugated drugs
Detailed Description:
This is a prospective open-label multicenter phase II platform trial The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs ADCs in patients with advanced breast cancer who had previously received ADCs
The primary endpoint is objective response rate ORR This trial aims to learn whether ADC rechallenge works in treating in ADC-treated metastatic breast cancer and identify which ADC works better for subsets on the basis of molecular characteristics and ADC treatment history of their disease with high ORR Study drugs involved in this study including but not limited to SHR-A1811 HER2 ADC SHR-A1921 TROP2 ADC SHR-A2009 HER3 ADC and SHR-A2102 Nectin 4 ADC
This platform trial is adaptive design Novel ADC regimens with sufficiently high activities that show a high Bayesian predictive probability will graduate from the trial with their corresponding biomarker signatures ADCs will be dropped if they show a low probability of improved efficacy with any biomarker signature New ADCs will enter as those that have undergone testing complete their evaluation
Based on the existing four ADC treatment cohorts on this platform a maximum of 120 subjects were planned to be enrolled in each ADC treatment cohort According to the previous ADC treatment history and target the subjects were randomly assigned to each cohort by adaptive randomization On the basis of previous clinical data at our center we limited the enrollment of a minimum of 10 participants per cohort to avoid underrepresentation of any cohort During the course of the study ORR will be evaluated periodically for every additional 10 results according to the Bayesian monitoring method and the proportion of random assignment to each cohort will be adjusted according to the calculated posterior probability using response-adaptive randomization RAR Graduation successful validation or elimination failed validation of ADC rechallenge treatment will be considered according to the posterior probability of an ADC cohort and the data of primary efficacy endpoint secondary efficacy endpoints and safety endpoints Additional targeted regimens may be added to the platform regimen as feasible as assessed by the investigators and the protocol will be modified accordingly at that time
The efficacy was evaluated by CT or MRI every 6 weeks 1 week according to RECIST 11 Subjects with CR or PR were required to have radiologic response confirmation at least 4 weeks Tumor assessments were performed every 9 weeks 1 week after 36 weeks of treatment until disease progression initiation of new antineoplastic therapy withdrawal of consent loss to follow-up death or the end of the study whichever occurred first
The primary endpoint is objective response rate ORR This trial aims to learn whether ADC rechallenge works in treating in ADC-treated metastatic breast cancer and identify which ADC works better for subsets on the basis of molecular characteristics and ADC treatment history of their disease with high ORR Study drugs involved in this study including but not limited to SHR-A1811 HER2 ADC SHR-A1921 TROP2 ADC SHR-A2009 HER3 ADC and SHR-A2102 Nectin 4 ADC
This platform trial is adaptive design Novel ADC regimens with sufficiently high activities that show a high Bayesian predictive probability will graduate from the trial with their corresponding biomarker signatures ADCs will be dropped if they show a low probability of improved efficacy with any biomarker signature New ADCs will enter as those that have undergone testing complete their evaluation
Based on the existing four ADC treatment cohorts on this platform a maximum of 120 subjects were planned to be enrolled in each ADC treatment cohort According to the previous ADC treatment history and target the subjects were randomly assigned to each cohort by adaptive randomization On the basis of previous clinical data at our center we limited the enrollment of a minimum of 10 participants per cohort to avoid underrepresentation of any cohort During the course of the study ORR will be evaluated periodically for every additional 10 results according to the Bayesian monitoring method and the proportion of random assignment to each cohort will be adjusted according to the calculated posterior probability using response-adaptive randomization RAR Graduation successful validation or elimination failed validation of ADC rechallenge treatment will be considered according to the posterior probability of an ADC cohort and the data of primary efficacy endpoint secondary efficacy endpoints and safety endpoints Additional targeted regimens may be added to the platform regimen as feasible as assessed by the investigators and the protocol will be modified accordingly at that time
The efficacy was evaluated by CT or MRI every 6 weeks 1 week according to RECIST 11 Subjects with CR or PR were required to have radiologic response confirmation at least 4 weeks Tumor assessments were performed every 9 weeks 1 week after 36 weeks of treatment until disease progression initiation of new antineoplastic therapy withdrawal of consent loss to follow-up death or the end of the study whichever occurred first
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