S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumour Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers

Titre officiel

A Phase 1a/1b, Open-label, Multicentre Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumour Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers

Sommaire:

The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumour malignancies followed by an expansion phase of triple combinations.

Description de l'essai

Primary Outcome:

  • Adverse Events (AEs) (Dose escalation part)
  • Incidence of dose limiting toxicities (DLTs) (Dose escalation part)
  • Assessment of antitumour activity using RECIST v1.1 (Dose expansion part)
Secondary Outcome:
  • Objective Response Rate (Dose escalation part)
  • Clinical Benefit Rate (CBR) (Dose escalation and dose expansion parts)
  • Duration of response (DOR) (Dose escalation and dose expansion parts)
  • Progression Free Survival (PFS) (Dose escalation and dose expansion parts)
  • Overall Survival (OS) (Dose escalation and dose expansion parts)

Voir cet essai sur ClinicalTrials.gov

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