A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
Summary
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
Arms & interventions
- DrugALK202
Administered intravenously, once every 3 weeks
Outcome measures
Primary
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies.
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Time frame: Approximately 36 months
Secondary
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time frame: Approximately 36 months
To evaluate the immunogenicity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time frame: Approximately 36 months
To evaluate the biomarkers
Time frame: Approximately 36 months
Eligibility criteria
Study locations (2)
D&H Cancer Research Center Llc
Margate, Florida, 33063
Next Oncology
Fairfax, Virginia, 22031