A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC
Summary
A Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition to dosing with the standard dose of docetaxel (PDoc) of 75 milligrams/meter squared (mg/m\^2) once every 21-day cycle. Based on observations on the safety and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0 ug/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 ug/kg. Up to 30 additional participants may be enrolled to test these dose levels. The second portion of Phase 1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose escalation is administered every 21 days to approximately 50 participants with high hyaluronan (HA-high) prospectively measured in their tumor tissue.
Timeline
- Start
- 2015-02-10
- Primary completion
- 2016-08-09
- Completion
- 2016-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Pegvorhyaluronidase Alfa | Protein / enzyme biologic | 1.6 ug/kg | — |
| Subject | Pegvorhyaluronidase Alfa | Protein / enzyme biologic | 2.2 ug/kg | — |
| Subject | Pegvorhyaluronidase Alfa | Protein / enzyme biologic | 2.8 ug/kg | — |
| Subject | Pegvorhyaluronidase Alfa | Protein / enzyme biologic | 3 ug/kg | — |