This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.
Dose expansion of BP1001-A IV twice weekly (Maximum tolerated dose or Maximum admistered dose) plus paclitaxel IV weekly for 4 weeks (28-day cycle) for 6 cycles.
Holy Cross Hospital
Silver Spring, Maryland, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
RECRUITINGThe University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGIdentify Dose Limiting Toxicity (DLT) of BP1001-A
Identify DLT of BP1001-A using non-hematologic and and hematologic measures per NCI CTCAE criteria
Time frame: 30 days
Identify maximum tolerated dose (MTD) of BP1001-A
Identify MTD based on dose limiting toxicities (DLT) of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Time frame: 30 days
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A
Identify and grade TEAE of escalating doses of BP1001-A using non-hematologic and hematologic measures per NCI CTCAE criteria
Time frame: 30 days
Identify and grade Treatment-Emergent Adverse Events (TEAE) of BP1001-A in combination with paclitaxel
Identify and grade TEAE of BP1001-A in combination with paclitaxel using non-hematologic and hematologic measures per NCI CTCAE criteria
Time frame: 30 days
Frequency and severity of Adverse Events (AEs) of BP1001-A monotherapy and in combination with paclitaxel
Determine frequency and grade of AEs per NCI CTCAE criteria
Time frame: 30 days
Determine objective response rate (ORR) by biopsy
Determine ORR by tumor biopsy using Response Criteria in Solid Tumors (RECIST)
Time frame: 180 days
Determine objective response rate (ORR) by imaging
Determine ORR by MRI or CT imaging using Response Criteria in Solid Tumors (RECIST)
Time frame: 180 days
Describe duration of overall response (OR)
Describe duration of OR using tumor biopsy per RECIST
Time frame: 180 days
Describe duration of objective response (OR)
Describe duration of OR using MRI or CT imaging per RECIST
Time frame: 180 days
Describe duration of stable disease by imaging
Describe duration of stable using MRI or CT imaging per RECIST
Time frame: 180 days
Describe duration of stable disease by tumor biopsy
Describe duration of stable disease using tumor biopsy per RECIST
Time frame: 180 days
Describe progression-free survival (PFS) per RECIST by biopsy
Describe PFS using tumor biopsy per RECIST
Time frame: 360 days
Describe progression-free survival (PFS) per RECIST by imaging
Describe PFS using MRI or CT imaging per RECIST
Time frame: 360 days
Determine plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (Cmax)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using maximum plasma drug concentration (Cmax)
Time frame: 30 days
Determine plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (Tmax)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using time of maximal observed concentration (Tmax)
Time frame: 30 days
Determine plasma pharmacokinetics (PK)of BP1001-A monotherapy and in combination with paclitaxel (AUC)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using Area Under the Curve (AUC)
Time frame: 30 days
Determine plasma pharmacokinetics of BP1001-A monotherapy and in combination with paclitaxel (CL)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using clearance rate (CL)
Time frame: 30 days
Determine half-life plasma pharmacokinetics (PK) of BP1001-A monotherapy and in combination with paclitaxel (t1/2)
Evaluate in vivo PK of BP1001-A monotherapy and BP1001-A in combination with paclitaxel using mean terminal elimination half life (t1/2)
Time frame: 30 days
Frequency and severity of AEs of BP1001-A in combination with paclitaxel
Determine frequency and grade of AEs of BP1001-A in combination with paclitaxel per NCI CTCAE criteria
Time frame: 30 days
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