Recent Updates
Recently added Catalysts

STRO-001

Phase 1

B-cell Lymphoma | Small molecule | Oncology |Sutro Biopharma, Inc.|Last Updated: Jun 11, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03424603Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell MalignanciesPHASE1 COMPLETED 70 — — Feb 22, 2018Mar 15, 2024Jun 11, 202422 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-001)
18 months

Incidence of adverse events (AEs) observed across STRO-001 dose levels

Part 1: Define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of STRO-001
18 months

Frequency of dose-limiting toxicity and exposure across STRO-001 dose levels

Part 2: Evaluate preliminary anti-tumor activity (multiple myeloma patients)
24 months

Objective response rates per International Myeloma Working Group (IMWG) criteria for response assessment

Part 2: Evaluate preliminary anti-tumor activity (NHL patients)
24 months

Objective response rates per the Lugano classification for response assessment

Secondary Endpoints
Part 1: Characterize the pharmacokinetics (PK) of STRO-001 by measuring the maximum plasma concentration (Cmax)
18 months
Part 1: Characterize the PK of STRO-001 by measuring the half-life (t1/2) of STRO-001
18 months
Part 1: Characterize the PK of STRO-001 measuring the total area under the concentration versus time curve from zero to infinity (AUCinf)
18 months
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
STRO-001EXPERIMENTALintravenous
Interventions
NameTypeDescription
STRO-001DRUGintravenous antibody drug conjugate
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Key Inclusion Criteria: 1. Confirmation of diagnosis 2. Relapsed or relapsed/refractory disease 3. Age ≥ 18 years 4. ECOG performance status (0-2) 5. Life expectancy \> 3 months 6. Adequate bone marrow and renal functions 7. QTcF \<500 msec 8. Ability to comply with treatment, PK and test schedules...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Cutaneous T-Cell Lymphoma 4 trials
CompanyTickerTrialsLead PhaseDrugs
Soligenix, Inc.SNGX1PHASE3Hypericin
Incyte CorporationINCY2PHASE2Ruxolitinib, Pembrolizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1 — Undisclosed
Unlock Competitive Intelligence