Advanced Solid TumorPhase 1NCT05638334
Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
A Phase 1 study testing 89Zr-S095012 tracer and S095012 will be administered via an IV infusion in people with Advanced Solid Tumor, run by Institut de Recherches Internationales Servier at 1 site in Netherlands.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- 89Zr-S095012 tracer and S095012 will be administered via an IV infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Nov 2022to 14 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- 89Zr-S095012 tracer and S095012 will be administered via an IV infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-S095012 tracer and S095012 will be administered via an IV infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-S095012 tracer with S095012 | Experimental | Not described Receives: Drug: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PET/CT scan images
Visual analysis of target lesions
Measured: 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
Measured: Within 14 days following the tracer injection and baseline (before the first treatment administration)
PET/CT scan images
Visual analysis of target lesions
Measured: Up to 8 days following the first treatment administration
Parameters derived from PET scans for organs and tumour lesions
Change in Volume of interest
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Area under the curve (AUC)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start21 Nov 2022
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638334
- Sponsor's protocol ID
- CL1-95012-002
- Other IDs
- 2021-001764-20
- Status last verified
- Feb 2026
- First submitted
- 28 Oct 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier. * with a first patient enrolled as of 1 January 2004 onwards. * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05638334
- Acronym / sponsor ID
- CL1-95012-002
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-S095012 tracer with S095012 | Experimental | Drug: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-S095012 tracer and S095012 will be administered via an IV infusionImaging 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. | Drug | 89Zr-S095012 tracer with S095012 |
Primary outcome
Change in PET/CT scan images
Time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
Visual analysis of target lesions
Change in PET/CT scan images
Time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration)
Visual analysis of target lesions
PET/CT scan images
Time frame: Up to 8 days following the first treatment administration
Visual analysis of target lesions
Parameters derived from PET scans for organs and tumour 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 Volume of interest
Parameters derived from PET scans for organs and tumour lesions
Time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration)
Change in Volume of interest
Parameters derived from PET scans for organs and tumour lesions
Time frame: Up to 8 days following first treatment administration
Volume of interest
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
Time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
Change in Standardised uptake value (SUV)
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
Time frame: Within 14 days following the tracer injection and baseline ( before the first treatment administration)
Change in Standardised uptake value (SUV)
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
Time frame: 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)
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)
Area under the curve (AUC)
Serum PK parameters of 89Zr-S095012 at baseline (Part B)
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
Area under the curve (AUC)
Serum PK parameters of 89Zr-S095012 on treatment (Part C- schedule 1)
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
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.
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
5 secondary outcomes
Serum PK parameters of S095012 during the range finding period (Part A)
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)
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)
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
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).
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. 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: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier. * with a first patient enrolled as of 1 January 2004 onwards. * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-S095012 tracer and S095012 will be administered via an IV infusion in people with Advanced Solid Tumor, run by Institut de Recherches Internationales Servier at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PET/CT scan images (time frame: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.