To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies
To determine the safety and tolerability of docetaxel as Oradoxel
To determine the incidence of unacceptable toxicity with Oradoxel
To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel
To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel
To evaluate tumor response
To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies
To determine the recommended Phase 2 dose of paclitaxel as Oraxol
To determine the safety and tolerability of paclitaxel as Oraxol
To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol
To evaluate the tumor response
While radiation is an essential component to the treatment of glioblastoma, it's use is limited due to toxicity when higher doses are attempted. Rhenium is a compund which releases radiation in small particles that are absorbed after only a fraction of an inch. This limited penetration means that high doses potentially can be given without the toxicity of other forms of radiation. In order for the radiaiton to be retained within the tumor, it has been packaged in microscopic fat like particles termed nanoliposomes. These facilitate the uptake of the radiation particles by the tumor. In order to better characterize this form of radiation therapy, it is being administered in patients who have failed other forms of therapy for glioblastoma. The treatment is administered by tubing inserted into the center of the tumor in the operating room. There are two portionms to this study. The first involves progressively increasing doses until the most tolerable dose can be identified. The second portion of the study involves a larger number of patients being treated at the determined most tolerable dose to better evalaute how well the treatment works.
This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma.
The study will enroll up to 48 patients from at least 2 cancer centers in the US.
In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health.
Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
Primary Objectives Phase 1
Evaluate the safety and tolerability of LYC-55716
Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Determine the objective response rate according to response evaluation criteria in solid
tumors (RECIST) v1.1
Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1
Determine the durability of any observed objective response
Determine the duration of response
Determine progression-free survival (PFS) and overall survival (OS)
Determine suitability of the RP2D for further study
Characterize the pharmacokinetics (PK) of LYC-55716
Assess tumor activity in subjects with locally advanced or metastatic cancer according to
immune-related response evaluation criteria in solid tumors (irRECIST)
Exploratory analysis of metabolite in plasma
Assess changes in circulating tumor markers (eg, cytokines/chemokines)