Phase 1 trials of PEGylated recombinant human hyaluronidase PH20 in patients with advanced solid tumours.

ABSTRACT:

Background

Hyaluronan accumulation in tumour stroma is associated with reduced survival in preclinical cancer models. PEGPH20 degrades hyaluronan to facilitate tumour access for cancer therapies. Our objective was to assess safety and antitumour activity of PEGPH20 in patients with advanced solid tumours.

Methods

In HALO-109-101 (N=14), PEGPH20 was administered intravenously once or twice weekly (0.5 or 50 μg kg^-1) or once every 3 weeks (0.5-1.5 μg kg^-1). In HALO-109-102 (N=27), PEGPH20 was administered once or twice weekly (0.5-5.0 μg kg^-1), with dexamethasone predose and postdose.

Results

Dose-limiting toxicities included grade ⩾3 myalgia, arthralgia, and muscle spasms; the maximum tolerated dose was 3.0 μg kg^-1 twice week

SUBMITTER: Infante JR 

PROVIDER: S-EPMC5785735 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature