A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors
This study is an open-label, Phase 1, study to evaluate the safety, tolerability, PK, and PD profiles of HOT-1030 as a monotherapy to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
42
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Shanghai Huaota Biopharmaceutical Co., Ltd.
Shanghai, Shanghai Municipality, China
RECRUITINGSafety and tolerability as measured by incidence of AEs (Adverse Events)
Incidence and severity of AEs, Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time frame: through study completion, an average of 1 year
Area Under Curve (AUC) of HOT-1030
Area under the concentration-time curve of HOT-1030 in plasma over the time interval from 0 extrapolated to infinity
Time frame: 42 days
Maximum Serum Concentration (Cmax) of HOT-1030
Maximum Serum Concentration (Cmax) in plasma
Time frame: 42 days
Antitumor Activity of HOT-1030 in Patients With advanced Solid Tumors
Response is defined as a Complete Response + Partial Response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: through study completion, an average of 1 year
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