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

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Code de protocole Servier: CL1-95012-001 Sponsor: Servier Bio-Innovation LLC Identifiant Clinicaltrials.gov: NCT05159388 Numéro EudraCT: 2019-003456-36

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Comment participer à l'étude ?
Si vous pensez être éligible pour cette étude (voir
critères d'éligibilité
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
Nom: Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone: +33 1 55 72 60 00
L'étude a 11 centres

Description de l'étude

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.
Titre officiel: A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors
Indications
Solid Tumor
Interventions / Traitements
  • PRS-344/S095012
Autres numéros d'identification
  • CL1-95012-001

Critères d'éligibilité

Age éligible pour l’étude

18 ans et plus (Adulte, Adulte plus âgé)

Sexes

Homme/Femme

Accepte les volontaires en bonne santé

Non

  • 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.

Comment l'étude est-elle conçue ?

Allocation
N/A
Modèle d'étude interventionnelle
Groupe unique
Groupe de participants / Bras de traitement
Expérimental: PRS-344/S095012
PRS-344/S095012
Intervention / Traitement
Traitement: PRS-344/S095012
PRS-344/S095012 Monotherapy

Mots clés

Fournis par 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
Autres termes
Neoplasm Metastasis