Sym021 Monotherapy and in Combination With Sym022 or Sym023 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) as Monotherapy and in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumour Malignancies or Lymphomas

Summary:

The primary purpose of this study is to see if Sym021 is safe and tolerable as monotherapy and in combination with either Sym022 or Sym023 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:

• Part 1: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
• Part 2: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.

Secondary Outcome:

• Evaluation of the immunogenicity of Sym021 as a single agent and in combination with Sym022 and Sym023.
• 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 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. Sym021 will be given to patients in escalating dose cohorts; each patient will be given one fixed dose level. Part 2 of this study will evaluate the safety, tolerability, and DLTs to establish the MTD and/or RP2D of sequential escalating doses of Sym022 and Sym023 when administered Q2W in combination with the RP2D of Sym021, each by IV infusion. Dose levels of Sym021+Sym022 and Sym021+Sym023 will be evaluated until for each combination the MTD is identified, a maximum administered dose (MAD) is reached, or until a RP2D for the added mAb (Sym022 or Sym023) in combination with Sym021 is selected. Each patient will be given one fixed dose level of an assigned combination.

View this trial on ClinicalTrials.gov