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 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, including epithelial ovarian cancer, endometrial cancer, fallopian tube cancer, and primary peritoneal carcinoma.
STRO-002 targets folate receptor alpha (FolRα), a protein commonly expressed on the surface of certain cancer cells. By binding to this receptor, the antibody drug conjugate aims to deliver a cytotoxic agent directly to tumor cells expressing FolRα.
STRO-002 is being developed by Sutro Biopharma, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol STRO.
STRO-002 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 1 trials are listed, one completed and one currently recruiting participants.
STRO-002 has two Phase 1 clinical trials. NCT03748186, a completed study in ovarian and endometrial cancers with 136 participants, and NCT06238687, a recruiting study in Chinese adults with epithelial ovarian cancer and other advanced malignant solid tumors with a target enrollment of 132 participants.
STRO-002 is also known by the name luveltamab tazevibulin. It is an antibody drug conjugate targeting folate receptor alpha, being developed by Sutro Biopharma for the treatment of ovarian cancer and other solid tumors.