A Phase 1/2 interventional study of STRO-002 in Neoplasm Malignant, sponsored by Tasly Pharmaceutical Group Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Tasly Pharmaceutical Group Co., Ltd · Phase 1/2, Interventional, and Treatment
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).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Tasly Pharmaceutical Group Co., Ltd is the lead sponsor of 32 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who are required to take folic acid-containing supplements, e.g., folate deficiency.
STRO-002 3.5 mg/kg Open Lable
Biological: STRO-002
STRO-002 4.3 mg/kg Open Lable
Biological: STRO-002
STRO-002 5.2 mg/kg Open Lable
Biological: STRO-002
Recurrent and/or progressive ovarian epithelial cancer, confirmed by immunohistochemistry \[IHC\] testing with FolRα positive expression (TPS ≥ 75%).
Biological: STRO-002
Recurrent and/or progressive ovarian epithelial cancer, confirmed by IHC testing with FolRα positive expression (25% ≤ TPS \< 75%).
Biological: STRO-002
Recurrent and/or progressive endometrial cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%).
Biological: STRO-002
Recurrent and/or progressive non-small-cell lung cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%).
Biological: STRO-002
Recurrent and/or progressive triple-negative breast cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%).
Biological: STRO-002
STRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the anti-tumor activity of cytotoxic drugs.
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)
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.
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Tasly Pharmaceutical Group Co., Ltd