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

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Servier Protocol Code: CL1-95012-002 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT05638334 EudraCT Number: 2021‐001764‐20

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 1 location

Study description

This study was done to assess how a new cancer drug called S095012 behaves in the body and targets cancer in participants with advanced solid tumours.

Solid tumour cancers are abnormal growths of cancer cells in organ(s) of the body such as the lung, breast, or brain. Advanced solid tumour can be locally advanced or metastatic. Locally advanced means that the cancer has grown outside the part of the body where it started in but has not yet spread to other parts of the body. Metastatic means that the cancer has spread to other parts of the body.

In the body, S095012 is intended to bind to 2 proteins: one called PD-L1 and the other called 4-1BB. PD-L1 proteins are present on tumour cells, helping them avoid the immune system. 4-1BB proteins are present on immune cells. When activated, 4-1BB can boost immune cells to attack and destroy tumour cells. S095012 is designed to block PD-L1 on tumour cells, while activating 4-1BB in immune cells. If the treatment is effective, S095012 should block the escape mechanism of the tumour cells and activate the immune cells in the neighbourhood of the tumour cells to destroy them.

To understand how and where S095012 moves in the body, researchers used a special imaging technique called positron emission tomography (PET) scans. They used a tracer drug called 89Zr-S095012 to track S095012 in the body. This tracer was made by adding a tiny, safe amount of a radioactive (emits radiations) substance called zirconium-89 to S095012. This made 89Zr-S095012 visible on the PET scans, allowing doctors to see where the study drug moved in the body.

The main objectives of this study were:

  • To determine the appropriate amount of S095012 to use for imaging and to select the best moments for the imaging.
  • To assess how 89Zr-S095012 moved in the body and how much of it was taken up by tumours.
  • To see how 89Zr-S095012 was processed by the body.
  • To look at the safety of 89Zr-S095012 and S095012.
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
Results
English (USA)
Nederlands (Nederland)
English (USA)
Conditions
Advanced Solid Tumor
Interventions / Treatments
  • 89Zr-S095012 tracer and S095012 will be administered via an IV infusion
Other study id numbers
  • CL1-95012-002

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years old.
  • Have a locally advanced or metastatic solid tumour for which standard treatment options were not available, were no longer working, or were not tolerated.
  • Have at least one tumour area that could be measured.
  • Have adequate organ function.

Participants could not take part in the study if:

  • Their cancer had spread to the brain and was causing symptoms, or they were taking medications that weaken the immune system.
  • They had a primary cancer of the brain or spinal cord. This means that their cancer started in the brain or spinal cord, rather than having spread there from other parts of the body.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: 89Zr-S095012 tracer with S095012
Intervention / Treatment
Drug: Drug: 89Zr-S095012 tracer and S095012

During the imaging period, participants received 89Zr-S095012 through infusion (injection given slowly) on imaging and S095012 through infusion, along with 89ZrS095012. S095012 was given in small amount to prevent the tracer from leaving the body too quickly. During the treatment period, S095012 was given through infusion every 2 weeks in each cycle of treatment.