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Home » Find Clinical Trials » A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

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Servier Protocol Code: CL1-95012-001 Sponsor: Servier Bio-Innovation LLC Clinicaltrials.gov Identifier: NCT05159388 EudraCT Number: 2019-003456-36

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How to participate in this 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 can’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 11 locations

Study description

This study was done to test a new cancer drug called S095012 (also known as PRS-344/S095012) in participants with advanced solid tumors.

Solid tumors are abnormal growths of cancer cells in organ(s) of the body such as the lung, breast, or brain. Advanced solid tumors can be locally advanced or metastatic. Locally advanced means that the cancer has grown beyond the area where it first started, but it 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 tumor cells, helping them avoid or escape the immune system (the body’s defense system). This is called an immune escape mechanism.

4-1BB proteins are present on immune cells. When activated, 4-1BB can boost immune cells to attack and destroy tumor cells.

S095012 is designed to block PD-L1 on tumor cells, while activating 4-1BB in immune cells. If the treatment is effective, S095012 should block the escape mechanism of the tumor cells and activate the immune cells in the neighbourhood of the tumor cells to destroy them.

The main objectives of this study were:

  • To look at the safety of S095012.
  • To find the highest dose of S095012 that participants could take without too much risk (highest tolerated dose). This highest tolerated dose helps to find the recommended dose (the one that is both safe and effective for participants).
  • To see how well S095012 works in participants with solid tumors.
Official title: A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors
Conditions
Solid Tumor
Interventions / Treatments
  • PRS-344/S095012
Other study id numbers
  • CL1-95012-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years old.
  • Have solid tumor that worsened despite previous treatments.
  • Have good blood, kidney and liver function.

Participants were not included in the study if they had:

  • Received prior medicines similar to S095012.
  • Any major surgery within 4 weeks of starting the study.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: PRS-344/S095012
PRS-344/S095012
Intervention / Treatment
Drug: PRS-344/S095012
PRS-344/S095012 Monotherapy

Keywords

Provided by Servier
Solid Tumor = Phase 1/2 Open-label Dose escalation Metastatic PRS-344 S095012 PRS-344/S095012 Anticalin protein Bi-specific 4-1BB CD137 PD-L1
Additional Relevant MeSH Terms Glioma
Neoplasm Metastasis