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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638334
• Other study ID #: CL1-95012-002
• Secondary ID: 2021-001764-20
• Status: Recruiting
• Phase: Phase 1
• Start date: November 21, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Servier
• Contact: Institut de Recherches Internationales Servier Clinical Studies
• Phone: +33155724366
• Email: scientificinformation[@]servier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: September 30, 2025
• Est. primary completion date: June 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC locatie VU - Medisch Centrum	Amsterdam
Netherlands	UMC Gronningen Oncologie	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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)
Primary	PET/CT scan images	Visual analysis of target lesions	Up to 8 days following the first treatment administration
Primary	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))
Primary	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)
Primary	Parameters derived from PET scans for organs and tumour lesions	Volume of interest	Up to 8 days following first treatment administration
Primary	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))
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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	Serum PK parameters of S095012 during the range finding period (Part A)	Area under the curve (AUC)	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)
Secondary	Serum PK parameters of S095012 at baseline (Part B)	Area under the curve (AUC)	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
Secondary	Serum PK parameters of S095012 on treatment (Part C - schedule 1)	Area under the curve (AUC)	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
Secondary	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
Secondary	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)	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).

External Links

•   Find Results on Servier Clinical Trial Data website