Neoplasms Clinical Trial
Official title:
Phase Ia/Ib, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, A Glycoengineered Antibody Against HER3, Administered Either Alone (Part A) or in Combination With Cetuximab (Part B) or in Combination With Erlotinib (Part C) in Patients With Metastatic and/or Locally Advanced Malignant HER3-Positive Solid Tumors of Epithelial Cell Origin
This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety,
pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or
erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive
solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599
as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in
Part C) followed by an extension phase for each part.
In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled
RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo
biodistribution and organ pharmacokinetics of RO5479599.
n/a
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