This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig (PT217) as a monotherapy and in combination with chemotherapy.
18 years or older and able to sign informed consent and comply with the protocol.
Measurable disease as defined by RECIST v1.1 criteria for solid tumors.
NECs that have transformed from NSCLC are not eligible.
Substudy C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum sensitive (defined as patients who experienced disease progression at least 90 days after their last platinum based chemotherapy) and are eligible for CE treatment rechallenge.
Women who are pregnant or lactating.
Women of child-bearing potential (WOCBP) who do not use adequate birth control.
Autoimmune disease requiring systemic treatment within the past twelve months.
Phanes Therapeutics
Lead sponsor
Hoffmann-La Roche
Collaborator