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STRO-002

Phase 1

Neoplasm Malignant | Monoclonal antibody | Oncology |Sutro Biopharma, Inc.|Last Updated: Feb 2, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment132
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06238687A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid TumorsPHASE1 RECRUITING 132 — — Nov 8, 2023Dec 30, 2027Feb 2, 20241 China
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Study Endpoints
Primary Endpoints
DLT Assessment
From Day1 to Day21 after first dose of STRO-002

Toxicity associated with the treatment of the investigational drug STRO-002.

AE Assessment
From first dose of STRO-002 until 28 days after the last dose of STRO-002

The frequency of AE

AUC
From first dose of STRO-002 until 28 days after the last dose of STRO-002.

PK parameter：area under the concentration-time curve (AUC)

Cmax
From first dose of STRO-002 until 28 days after the last dose of STRO-002.

PK parameter：Cmax

Half life (t1/2)
From first dose of STRO-002 until 28 days after the last dose of STRO-002.

PK parameter：half life (t1/2)

Overall response rate (ORR)
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

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1

Determine the recommended phase II dose (RP2D)
From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Secondary Endpoints
Occurrence of positive anti-drug antibodies (ADAs) and changes over time.
From first dose of STRO-002 until 28 days after the last dose of STRO-002.
Duration of response (DOR)
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)
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1(Phase I)EXPERIMENTALSTRO-002 3.5 mg/kg Open Lable
Cohort 2(Phase I)EXPERIMENTALSTRO-002 4.3 mg/kg Open Lable
Cohort 3(Phase I)EXPERIMENTALSTRO-002 5.2 mg/kg Open Lable
Cohort A(Phase IIa)EXPERIMENTALRecurrent and/or progressive ovarian epithelial cancer, confirmed by immunohistochemistry \[IHC\] testing with FolRα positive expression (TPS ≥ 75%).
Cohort B(Phase IIa)EXPERIMENTALRecurrent and/or progressive ovarian epithelial cancer, confirmed by IHC testing with FolRα positive expression (25% ≤ TPS \< 75%).
Cohort C(Phase IIa)EXPERIMENTALRecurrent and/or progressive endometrial cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%).
Cohort D(Phase IIa)EXPERIMENTALRecurrent and/or progressive non-small-cell lung cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%).
Cohort E(Phase IIa)EXPERIMENTALRecurrent and/or progressive triple-negative breast cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%).
Interventions
NameTypeDescription
STRO-002BIOLOGICALSTRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the anti-tumor activity of cytotoxic drugs.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06238687studyFirstPostDate: changed