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STRO-001

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
STRO-001EXPERIMENTALintravenous

Interventions

NameTypeDescription
STRO-001DRUGintravenous antibody drug conjugate
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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
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Competitive Landscape -Cutaneous T-Cell Lymphoma 3 trials (matched to "B-cell Lymphoma")

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Frequently asked questions about STRO-001

What is STRO-001 used for?

STRO-001 is an investigational antibody drug conjugate being studied for the treatment of advanced B-cell malignancies, including B-cell lymphoma, non-Hodgkin lymphoma, multiple myeloma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, and indolent lymphoma. It is currently in clinical development and has not been approved by the FDA.

What does STRO-001 target?

STRO-001 targets CD74, a protein expressed on B cells. As an antibody drug conjugate, it is designed to deliver a cytotoxic agent to CD74-expressing cells. This mechanism is being evaluated in patients with advanced B-cell malignancies, including B-cell lymphoma and multiple myeloma.

Who makes STRO-001?

STRO-001 is being developed by Sutro Biopharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol STRO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced B-cell malignancies.

What phase is STRO-001 in?

STRO-001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of STRO-001 in patients with advanced B-cell malignancies has been completed, with results expected to inform further development.

What clinical trials is STRO-001 in?

STRO-001 has been studied in a Phase 1 clinical trial with the identifier NCT03424603. This completed study enrolled 70 participants with advanced B-cell malignancies, including B-cell lymphoma and multiple myeloma, at sites in the United States. The trial was uncontrolled and not randomized or double-blinded.

Is STRO-001 the same as an anti-CD74 antibody drug conjugate?

Yes, STRO-001 is an anti-CD74 antibody drug conjugate. It is designed to target CD74, a protein found on B cells, and deliver a cytotoxic payload. This investigational drug is being developed by Sutro Biopharma for the treatment of advanced B-cell malignancies.