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

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic solid tumors.

Key facts

Study ID

NCT05159388

Run by

Servier Bio-Innovation LLC

People needed

46

Starts

2021-09-08

Expected to finish

2025-04-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years on the day the consent is signed.
• 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.
• Patient should have a documented disease progression on prior therapy before entry into this study.
• Patients must have at least one measurable target lesion as per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
• Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab.
• 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.

You may not qualify if…

• 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.
• Patients who have received prior:
• Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
• Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
• Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
• Patients who have received 4-1BB agonists in the past.
• Patients who had a major surgery within 4 weeks prior to first administration of IMP.
• History of progressive multifocal leukoencephalopathy.
• Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Where it is running

• Carolina Bio Oncology — Huntersville, North Carolina, United States
• NEXT Oncology — San Antonio, Texas, United States
• Cabrini Oncology Research — Malvern, Victoria, Australia
• Chris O'Brian Lifehouse — Camperdown, Australia
• The Queen Elizabeth Hospital — Woodville South, Australia
• Institute Jules Bordet — Brussels, Belgium
• Universitair Ziekenhuis — Edegem, Belgium
• U.Z. Gent Medical Oncology — Ghent, Belgium
• Hospital Vall d'Hebron — Barcelona, Spain
• START — Madrid, Spain
• Hospital Universitario Gregorio — Madrid, Spain

Full record on ClinicalTrials.gov

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