Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours

NCT05638334 | Terminated Phase 1

• 2 other identifiers: CL1-95012-0022021-001764-20
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (15)

• 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)

  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

Secondary Outcomes (5)

• 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)

• 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

• 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

• 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

  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).

Study Arms (1)

89Zr-S095012 tracer with S095012

EXPERIMENTAL

Drug: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion

Interventions

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.

89Zr-S095012 tracer with S095012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR, a Servier Group company: collaborator

Study Sites (1)

UMC Gronningen Oncologie

Groningen, 9713 AZ, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: December 6, 2022
• Study Start: November 21, 2022
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• Access Criteria: 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.

Locations

NL (1)