This is a Phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB3008 as monotherapy in subjects with advanced solid tumors.
This first-in-human (FIH) study of BB3008 will evaluate safety, tolerability, pharmacokinetics (PK) efficacy and preliminary food effect of BB3008 in subjects with advanced solid tumors. The primary objective is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of BB3008 as monotherapy, and to evaluate the safety and tolerability of BB3008. The secondary objectives include the assessments of PK profile, preliminary efficacy, preliminary food effect (FE) and preliminary metabolites identification of BB3008. The exploratory objectives are to explore biomarkers and C-QTcF analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
BB3008 tablets will be administered orally once daily (QD).
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Number of subjects with dose limiting toxicities (DLTs)
To assess the safety and tolerability of BB3008 tablet as monotherapy in subjects with advanced solid tumors and to determine the maximum tolerated dose (MTD) of BB3008 tablet, and to provide a basis for determination of the recommended dose (RP2D) for Phase II clinical trials.
Time frame: Single dose to the end of Cycle 1 (each cycle is 21 days)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs will be characterized by type, seriousness, relationship to study treatment, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) and timing.
Time frame: From screening (Day -28 to Day -1) through up to 12 months or until disease progression
Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)
Blood samples will be collected for PK analyses
Time frame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Pharmacokinetic Assessments: Time to Peak Concentration (Tmax)
Blood samples will be collected for PK analyses
Time frame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Pharmacokinetic Assessments: Area under the plasma concentration-time curve (AUC)
Blood samples will be collected for PK analyses
Time frame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Pharmacokinetic Assessments: Elimination half-life (t½)
Blood samples will be collected for PK analyses
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Time frame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Objective response rate (ORR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Duration of response (DOR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Disease control rate (DCR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival (PFS)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months