Clinical trial NCT05638334: Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
Official title: An Open Label, Multicentre, Positron Emission Tomography (PET) Imaging Study Using Zirconium-89 to Investigate the Biodistribution and Tumour Uptake of a PD-L1x4-1BB Bispecific Antibody (S095012) in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2022-12-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated
* At least one measurable target lesion as per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis)
* Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)
* Negative test results for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards.

Exclusion Criteria:

* Participants with no available archived material and no tumour lesions amenable to biopsy
* Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis
* Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent)
* Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded.
* Participants who received either systemic corticosteroids (\> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded.
* Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis
* Participants with a history of progressive multifocal leukoencephalopathy
* Participants must not have a history of active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Primary outcomes:
measure: Change in PET/CT scan images
timeFrame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
measure: Change in PET/CT scan images
timeFrame: Within 14 days following the tracer injection and baseline (before the first treatment administration)
measure: PET/CT scan images
timeFrame: Up to 8 days following the first treatment administration
measure: Parameters derived from PET scans for organs and tumour lesions
timeFrame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
measure: Parameters derived from PET scans for organs and tumour lesions
timeFrame: Within 14 days following the tracer injection and baseline (before the first treatment administration)
measure: Parameters derived from PET scans for organs and tumour lesions
timeFrame: Up to 8 days following first treatment administration
measure: Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
timeFrame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
measure: Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
timeFrame: Within 14 days following the tracer injection and baseline ( before the first treatment administration)
measure: Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
timeFrame: Up to 8 days following first treatment administration
measure: Serum PK parameters of 89Zr-S095012 during the range finding period (Part A)
timeFrame: 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)
measure: Serum PK parameters of 89Zr-S095012 at baseline (Part B)
timeFrame: 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
measure: Serum PK parameters of 89Zr-S095012 on treatment (Part C- schedule 1)
timeFrame: 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
measure: 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.
timeFrame: In Part C (imaging period 2) between Day 1 and Day 8 of cycle 1 (the duration of cycle 1 is 28 days)
measure: Incidence and severity of adverse events
timeFrame: 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
measure: Number of patients discontinuing study intervention due to an adverse event
timeFrame: 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
Secondary outcomes:
measure: Serum PK parameters of S095012 during the range finding period (Part A)
timeFrame: 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)
measure: Serum PK parameters of S095012 at baseline (Part B)
timeFrame: 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
measure: Serum PK parameters of S095012 on treatment (Part C - schedule 1)
timeFrame: 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
measure: Organ and whole-body radiation exposure (milliSilvert per Mega Becquerel (mSv/MBq): Effective dose per organ and whole-body effective dose.
timeFrame: In Part A, B and C (imaging period 1) at Day-14
measure: Preliminary antitumour activity assessment of S95012
timeFrame: 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).
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMC Gronningen Oncologie
Study officials:
References: