Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumour Malignancies or Lymphomas

Official Title

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

Summary:

This is the first study to test Sym021 in humans. The primary purpose of this study is to see if Sym021 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumour malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.

Trial Description

Primary Outcome:

• Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.

Secondary Outcome:

• Evaluation of the immunogenicity of Sym021.
• 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)

This study will evaluate the preliminary safety, tolerability, and dose-limiting toxicities (DLTs) of Sym021, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) . The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by 30-minute intravenous (IV) infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumour malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available. If an MTD is not identified, a maximum administered dose (MAD) will be determined. Sym021 will be given to patients in escalating dose cohorts; each patient will be given one fixed dose level.

View this trial on ClinicalTrials.gov