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.
This study consists of two parts, Phase I (dose escalation and PK bridging) and Phase IIa (dose expansion). Subjects in each cohort of Phase I will be administered 3 scheduled dose levels of STRO-002 as monotherapy by intravenous infusion until intolerable toxicity, radiographic disease progression, or subject withdrawal for other reasons. 5 dose arms are tentatively set based on the available safety, PK and efficacy data of STRO-002 for the Phase IIa (dose expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
STRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the anti-tumor activity of cytotoxic drugs.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
DLT Assessment
Toxicity associated with the treatment of the investigational drug STRO-002.
Time frame: From Day1 to Day21 after first dose of STRO-002
AE Assessment
The frequency of AE
Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002
AUC
PK parameter:area under the concentration-time curve (AUC)
Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Cmax
PK parameter:Cmax
Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Half life (t1/2)
PK parameter:half life (t1/2)
Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Overall response rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Time frame: 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)
Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Occurrence of positive anti-drug antibodies (ADAs) and changes over time.
Occurrence of positive anti-drug antibodies (ADAs)
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Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Duration of response (DOR)
DOR is defined as the time from the first documented response (CR or PR evaluated by RECIST v1.1) until the time of first documentation of disease progression by RECIST v1.1.
Time frame: 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
Progression-free survival (PFS)
PFS is defined as a time from the first dose of STRO-002 to documented disease progression or death from any cause.
Time frame: 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
FolRα and cancer antigen 125 (CA-125) levels measured in tumor tissue
A CA-125 response is defined as at least a 50% reduction in CA-125 levels from a pretreatment sample, and the response must be confirmed and maintained for at least 28 days.
Time frame: From first dose of STRO-002 until 28 days after the last dose of STRO-002.