To assess the safety, tolerability, PK and preliminary efficacy of CD-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
CD-001 administered as an intravenous (IV) infusion.
Tianjin Medical University Cancer Institute&Hospital
Tianjin, China
RECRUITINGNumber of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Incidence of AE and serious adverse events (SAE)
According to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0)
Time frame: Up to 3 Years
The recommended dose for expansion (RDE) and/ or maximum tolerated dose (MTD) of CD-001 monotherapy
Time frame: Up to 3 Years
Maximum Observed Plasma Concentration (Cmax) of CD-001
Time frame: Up to 3 Years
Time to Achieve Cmax (Tmax) of CD-001
Time frame: Up to 3 Years
Area Under the Plasma Concentration-time Curve (AUC) of CD-001
Time frame: Up to 3 Years
Objective Response (OR)
Time frame: Up to 3 Years
Duration of Response (DOR)
Time frame: Up to 3 Years
Progression-Free Survival (PFS)
Time frame: Up to 1 Years
Disease Control Rate (DCR)
Time frame: Up to 3 Years
Overall Survival (OS)
Time frame: Up to 3 Years
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Frequency of anti-drug antibody (ADA) to CD-001
Time frame: Up to 3 Years