A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

Condition studied

Locally Advanced or Metastatic Solid Tumors

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence and nature of dose-limiting toxicities (DLTs) during Cycle 1 (28 days) of CR-001 administration, and maximum tolerated dose (MTD) characterization, if applicable, Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Severity and nature of TEAEs leading to dose modifications and treatment discontinuation

Endpoint detail

Determination of RP2D(s): The RP2D will be determined based on a review of available safety, tolerability, PK, PD, and clinical activity data, Serum PK parameters: area under the curve from time 0 extrapolated to infinity (AUC0--inf), area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast), maximum concentration (Cmax), time to maximum concentration (Tmax), volume of distribution (Vd), clearance (CL), and elimination half-life (t½) after a single dose and steady state PK parameters as appropriate, Incidence of participants with detectable antidrug antibodies (ADAs), Overall response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR) progression-free survival (PFS), overall survival (OS), and best percent change in target lesions