Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumour Malignancies

Titre officiel

A Phase 1, Open-Label, Multicentre Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym024 (Anti-CD73) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumour Malignancies

Sommaire:

The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumour malignancies.

Description de l'essai

Primary Outcome:

• Part I: To evaluate the incidence, severity and relationship of (S)AEs to establish the MTD/MAD of Sym024 monotherapy.
• Part II: To evaluate the incidence, severity and relationship of (S)AEs to establish MTD/MAD of Sym024 in combination with Sym021.
• Part III: To evaluate the incidence, severity and relationship of (S)AEs to further assess safety of Sym024 when administered alone or in combination with Sym021.

Secondary Outcome:

• Evaluation of the immunogenicity of Sym024 as a single agent and in combination with Sym024
• Evaluation of objective response (OR) or stable disease (SD)
• Time to progression (TTP) of disease
• Area under the concentration-time curve in a dosing interval (AUC)
• Maximum concentration (Cmax)
• Time to reach maximum concentration (Tmax)
• Trough concentration (Ctrough)
• Terminal elimination half-life (T½)
• Clearance (CL)

Part 1 of this study will assess the safety and tolerability to establish the maximum tolerated dose (MTD) (or the maximum administered dose [MAD]) and/or the selected dose(s) of Sym024 in patients with solid tumour malignancies. Part 2 of this study will assess the safety and tolerability to establish the MTD (or the MAD) and/or the selected dose(s) of Sym024 when administered in combination with Sym021 in patients with solid tumour malignancies. Part 3 of this study will assess the safety of Sym024 when administered alone or in combination with Sym021 in expanded cohorts of patients with solid tumour malignancies.

Voir cet essai sur ClinicalTrials.gov