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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
UMC Gronningen Oncologie
Groningen, Netherlands
Change in PET/CT scan images
Visual analysis of target lesions
Time frame: 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
Time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration)
PET/CT scan images
Visual analysis of target lesions
Time frame: Up to 8 days following the first treatment administration
Parameters derived from PET scans for organs and tumour lesions
Change in Volume of interest
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
Change in Standardised uptake value (SUV)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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 during the range finding period (Part A)
Area under the curve (AUC)
Time frame: 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 S095012 at baseline (Part B)
Area under the curve (AUC)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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).