Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
STRO-002 · 2 trials · 8 indications
Toxicity associated with the treatment of the investigational drug STRO-002.
The frequency of AE
PK parameter：area under the concentration-time curve (AUC)
PK parameter：Cmax
PK parameter：half life (t1/2)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Incidence of adverse events (AEs) observed across STRO-002 dose levels
Frequency of dose-limiting toxicity and exposure across STRO-002 dose levels
Frequency of dose-limiting toxicity and exposure across STRO-002 dose levels
Objective response rate per RECIST 1.1
Objective response rate per RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Cohort 1(Phase I) | EXPERIMENTAL | STRO-002 3.5 mg/kg Open Lable |
| Cohort 2(Phase I) | EXPERIMENTAL | STRO-002 4.3 mg/kg Open Lable |
| Cohort 3(Phase I) | EXPERIMENTAL | STRO-002 5.2 mg/kg Open Lable |
| Cohort A(Phase IIa) | EXPERIMENTAL | Recurrent and/or progressive ovarian epithelial cancer, confirmed by immunohistochemistry \[IHC\] testing with FolRα positive expression (TPS ≥ 75%). |
| Cohort B(Phase IIa) | EXPERIMENTAL | Recurrent and/or progressive ovarian epithelial cancer, confirmed by IHC testing with FolRα positive expression (25% ≤ TPS \< 75%). |
| Cohort C(Phase IIa) | EXPERIMENTAL | Recurrent and/or progressive endometrial cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%). |
| Cohort D(Phase IIa) | EXPERIMENTAL | Recurrent and/or progressive non-small-cell lung cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%). |
| Cohort E(Phase IIa) | EXPERIMENTAL | Recurrent and/or progressive triple-negative breast cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%). |
| STRO-002 treatment | EXPERIMENTAL | Dose Escalation: STRO-002 at increasing dose levels Dose Expansion: STRO-002 at 4.3 mg/kg and 5.2 mg/kg |
| Name | Type | Description |
|---|---|---|
| STRO-002 | BIOLOGICAL | STRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the anti-tumor activity of cytotoxic drugs. |
Inclusion Criteria: 1. Life expectancy \>3 months. 2. Subjects must have at least one measurable lesion (non-radiotherapy field) per RECIST v1.1. 3. The adverse reactions (ARs) of previous anti-tumor therapy must recover to NCI CTCAE v5.0 grade ≤ 1 (except for toxicity with no safety risks judged b...
STRO-002 is an investigational monoclonal antibody drug conjugate being studied for the treatment of ovarian cancer and other advanced malignant solid tumors. It is currently in Phase 1 clinical development for these indications.
STRO-002 targets folate receptor alpha (FolRα), a protein commonly expressed in certain cancers. It is designed as an antibody drug conjugate to deliver a cytotoxic agent to cancer cells expressing this receptor.
STRO-002 is being developed by Sutro Biopharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol STRO.
STRO-002 is currently in Phase 1 clinical trials. It is an investigational drug and has not yet been approved by regulatory authorities for any indication.
STRO-002 is being studied in two Phase 1 trials. NCT03748186 is a completed study in ovarian and endometrial cancers with 136 participants. NCT06238687 is an ongoing recruiting study in Chinese adults with epithelial ovarian cancer and other advanced solid tumors.
Yes, STRO-002 is an anti-folate receptor alpha (FolRα) antibody drug conjugate. It is designed to target and deliver chemotherapy directly to cancer cells that express the FolRα protein.