This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.
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DLT Assessment
Timeframe: From Day1 to Day21 after first dose of STRO-002
AE Assessment
Timeframe: From first dose of STRO-002 until 28 days after the last dose of STRO-002
AUC
Timeframe: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Cmax
Timeframe: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Half life (t1/2)
Timeframe: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Overall response rate (ORR)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Determine the recommended phase II dose (RP2D)
Timeframe: From first dose of STRO-002 until 28 days after the last dose of STRO-002.