The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.
This phase Ia and Ib/II, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and phase 2 dose (RP2D). Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. Dose-limiting toxicity (DLT) observation period is 28 days. Patients in phase Ib/II part will be recruited into certain tumor cohorts and receive RP2D CBP-1019 iv infusion every two weeks. Primary efficacy of objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib/II stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Light yellow to yellow loose lumps or powder;50mg/vial; Infusion for 90 minutes (± 10 minutes), once every 2 weeks.
TOI Clinical Research LLC
Cerritos, California, United States
RECRUITINGFlorida Cancer Specialists & Research Institute
Orlando, Florida, United States
RECRUITINGNorthwell Health Inc.
Manhasset, New York, United States
Incidence and severity of Adverse Events (AEs)
Safety and tolerability: incidence of dose limiting toxicities (DLTs)、treatment emergent adverse events、serious adverse events (SAEs)、electrocardiogram (ECG) and clinical laboratory tests per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE 5.0).
Time frame: up to 12 months
MTD/RP2D of CBP-1019.
Dose limiting toxicity (DLT) will be assessed by NCI CTCAE v5.0.Critical decisions as DLT/MTD/RP2D evaluation and dose escalation will be made by Safety monitoring committee (SMC).
Time frame: Up to 28 days after the first dose of CBP-1019
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Next Oncology
Fairfax, Virginia, United States
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITING