A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Escalation: Number of patients with Dose Limiting Toxicities (DLTs) during Cycle 1

  Measured over: 4 weeks

• Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer, and combination cohorts): Safety and tolerability: AEs and SAEs

  Measured over: 6-12 months

• Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): Treatment discontinuations and dose modifications due to AEs

  Measured over: 6-12 months

• Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): Best overall response (BOR)

  Measured over: 36 months

• Expansion (Single agent - non-randomized, and combination cohorts): Objective response rate (ORR)

  Measured over: 36 months

• Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg: TEAEs

  Measured over: 8 weeks

• Expansion: (subcutaneous cohort): Bioavailability of subcutaneous vs intravenous administration

  Measured over: 6 weeks

• Expansion: (subcutaneous cohort): Area under the concentration versus time curve from time zero to time t [AUC0-t]

  Measured over: 6 weeks

• Expansion: (subcutaneous cohort): Maximum plasma concentration [Cmax]

  Measured over: 8 weeks

• Expansion: (subcutaneous cohort): Minimum plasma drug concentration [Ctrough]

  Measured over: 6 weeks

Changes Tremor has spotted