Recent Updates
Recently added Catalysts

STRO-001

Phase 1

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

STRO-001 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2018

STRO-001 target and mechanism

Molecular targetCD74
Target classProtein
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

STRO-001 clinical trials

STRO-001 · 1 trial · 8 indications

Phase 1 1
NCT03424603Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell MalignanciesB-cell Lymphoma
COMPLETED70 Analytics
PHASE1COMPLETED
Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
B-cell LymphomaUnlock trial analytics

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 to 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 7 trials (matched to "B-cell Lymphoma")

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Incyte CorporationINCY2PHASE2Ruxolitinib
Unlock Competitive Intelligence

Frequently asked questions about STRO-001

What is STRO-001?

STRO-001 is an investigational anti-CD74 antibody drug conjugate developed by Sutro Biopharma, Inc. for advanced B-cell malignancies, including B-cell lymphoma. It delivers a cytotoxic payload to cells expressing CD74. It is in Phase 1 clinical development and has not been approved by the FDA.

What is STRO-001 used for in B-cell lymphoma?

STRO-001 is being studied for the treatment of advanced B-cell malignancies, including B-cell lymphoma, non-Hodgkin lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, indolent lymphoma, and multiple myeloma. It is investigational and has not been approved for any indication.

What does STRO-001 target?

STRO-001 targets CD74, a protein expressed on B cells and certain hematologic malignancies. As an antibody drug conjugate, STRO-001 binds CD74 and delivers a cytotoxic payload directly to CD74-expressing tumor cells. This targeted approach aims to concentrate anti-tumor activity on malignant B cells.

Who is developing STRO-001?

STRO-001 is being developed by Sutro Biopharma, Inc., which trades on the Nasdaq under the ticker STRO. The company is the sponsor of the clinical program evaluating STRO-001 in advanced B-cell malignancies.

What phase is STRO-001 in?

STRO-001 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 trial evaluating STRO-001 has been completed.

What clinical trials is STRO-001 in?

STRO-001 was evaluated in one Phase 1 clinical trial, NCT03424603, titled Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies. The trial enrolled 70 patients in the United States and has been completed. It was an uncontrolled, open-label study.