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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001764-20 | EudraCT Number |
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Sponsor decision
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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
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The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated with S095012 (PD-L1x4-1BB bispecific antibody)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 89Zr-S095012 tracer with S095012 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-S095012 tracer and S095012 will be administered via an IV infusion | Drug | Imaging period 1 (Part A and Part B): The tracer will be administered with S095012 at non-therapeutic mass dose. The optimal mass dose of S095012 will be investigated in part A, and used in part B. Treatment period (Part A to C): S095012 will be administered with multiple 28 days- cycles in a Q2W schedule. Imaging period 2 (Part C): A second tracer dose will be administered at 1st treatment dose of S095012 in part C. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PET/CT scan images | Visual analysis of target lesions | Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period)) |
| Change in PET/CT scan images | Visual analysis of target lesions | Within 14 days following the tracer injection and baseline (before the first treatment administration) |
| PET/CT scan images | Visual analysis of target lesions | Up to 8 days following the first treatment administration |
| Parameters derived from PET scans for organs and tumour lesions | Change in Volume of interest | Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period)) |
| Parameters derived from PET scans for organs and tumour lesions | Change in Volume of interest | Within 14 days following the tracer injection and baseline (before the first treatment administration) |
| Parameters derived from PET scans for organs and tumour lesions | Volume of interest | Up to 8 days following first treatment administration |
| Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues | Change in Standardised uptake value (SUV) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum PK parameters of S095012 during the range finding period (Part A) | Area under the curve (AUC) | plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration (during the dose ranging period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Gronningen Oncologie | Groningen | 9713 AZ | Netherlands |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period)) |
| Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues | Change in Standardised uptake value (SUV) | Within 14 days following the tracer injection and baseline ( before the first treatment administration) |
| Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues | Standardised uptake value (SUV) | Up to 8 days following first treatment administration |
| Serum PK parameters of 89Zr-S095012 during the range finding period (Part A) | Area under the curve (AUC) | radioactive plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration (during the dose ranging period) |
| Serum PK parameters of 89Zr-S095012 at baseline (Part B) | Area under the curve (AUC) | radioactive plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration |
| Serum PK parameters of 89Zr-S095012 on treatment (Part C- schedule 1) | Area under the curve (AUC) | radioactive plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day 1) and on Day 2, Day 3, Day 5 and Day 8 following the first treatment administration |
| Change in Comparison of 89Zr-S095012 tumour uptake (as described using Standardised Uptake Value and concentrations) before and on treatment with different doses of S095012. | In Part C (imaging period 2) between Day 1 and Day 8 of cycle 1 (the duration of cycle 1 is 28 days) |
| Incidence and severity of adverse events | Throughout the study up to 30 days after the last IMP for all AEs, or up to 90 days for all AEs related to the IMP and death |
| Number of patients discontinuing study intervention due to an adverse event | Throughout the study up to 30 days after the last IMP for all AEs, or up to 90 days for all AEs related to the IMP and death |
| Serum PK parameters of S095012 at baseline (Part B) |
Area under the curve (AUC) |
| plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration |
| Serum PK parameters of S095012 on treatment (Part C - schedule 1) | Area under the curve (AUC) | plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day 1) and on Day 2, Day 3, Day 5, Day 8 and Day 15 following the first treatment administration |
| Organ and whole-body radiation exposure (milliSilvert per Mega Becquerel (mSv/MBq): Effective dose per organ and whole-body effective dose. | In Part A, B and C (imaging period 1) at Day-14 |
| Preliminary antitumour activity assessment of S95012 | Percentage of patients who achieved complete response or partial response (ie, objective response rate (ORR)) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (V1.1) | The events to be studied are Complete Response or Partial Response, from the first treatment administration up to one year (for patients with confirmed Complete response) or 2 years (for Patients with confirmed Partial Response). |