Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
Phase 1
Terminated
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion
- Registration Number
- NCT05638334
- Lead Sponsor
- Institut de Recherches Internationales Servier
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 89Zr-S095012 tracer with S095012 89Zr-S095012 tracer and S095012 will be administered via an IV infusion -
- Primary Outcome Measures
Name Time Method Change in PET/CT scan images Within 14 days following the tracer injection and baseline (before the first treatment administration) Visual analysis of target lesions
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues Up to 8 days following first treatment administration Standardised uptake value (SUV)
Serum PK parameters of 89Zr-S095012 during the range finding period (Part A) 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) Area under the curve (AUC)
Serum PK parameters of 89Zr-S095012 at baseline (Part B) 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 Area under the curve (AUC)
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) 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 PET/CT scan images Up to 8 days following the first treatment administration Visual analysis of target lesions
Parameters derived from PET scans for organs and tumour lesions Up to 8 days following first treatment administration Volume of interest
Serum PK parameters of 89Zr-S095012 on treatment (Part C- schedule 1) 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 Area under the curve (AUC)
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
- Secondary Outcome Measures
Name Time Method Serum PK parameters of S095012 at baseline (Part B) 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 Area under the curve (AUC)
Serum PK parameters of S095012 on treatment (Part C - schedule 1) 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 Area under the curve (AUC)
Preliminary antitumour activity assessment of S95012 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). 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)
Serum PK parameters of S095012 during the range finding period (Part A) 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) Area under the curve (AUC)
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
Trial Locations
- Locations (1)
UMC Gronningen Oncologie
🇳🇱Groningen, Netherlands