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A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
Servier Protocol Code:
CL1-95012-001
Sponsor:
Servier Bio-Innovation LLC
Clinicaltrials.gov Identifier:
NCT05159388
EudraCT Number:
2019-003456-36
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
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.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
The trial is an open-label, multi-center safety trial of PRS-344/S095012. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2)). The expansion part of the trial will be initiated once the optimal biological dose (OBD) has been determined.
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
The treatment(s) given to the participants in the study.
- PRS-344/S095012
Other study id numbers
Other identification numbers the study may be known by.
- CL1-95012-001
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- 1. Age ≥18 years on the day the consent is signed.
- 2. Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
- 3. Patient should have a documented disease progression on prior therapy before entry into this study.
- 4. Patients must have at least one measurable target lesion as per RECIST 1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
- 7. Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab.
- 8. A female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.
- 1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid <10 mg/day prednisone or equivalent) is allowed.
- 2. Patients who have received prior:
- 1. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
- 2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
- 3. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
- 3. Patients who have received 4-1BB agonists in the past.
- 4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.
- 5. History of progressive multifocal leukoencephalopathy.
- 6. Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Single Group
A single group study design involves studying one group of participants who all receive the same treatment. Researchers observe the group's results to understand the effects of the treatment.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
PRS-344/S095012
PRS-344/S095012
Intervention / Treatment
The treatment(s) given to the participants in the study.
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