Solid Tumors Clinical Trial
Official title:
A Phase 1b, Open-Label, Multi-Center, Dose Escalation Study of the Safety, Pharmacokinetics, and Therapeutic Activity of Cergutuzumab Amunaleukin, an Immunocytokine, Which Consists of a Variant of Interleukin 2 (IL 2v), That Targets Carcinoembryonic Antigen (CEA), and Atezolizumab, an Antibody That Targets Programmed Death-Ligand 1 (PD-L1), Administered Intravenously, in Patients With Locally Advanced and/or Metastatic Solid Tumors
This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.
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Status | Clinical Trial | Phase | |
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Active, not recruiting |
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