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A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer

NCT ID: NCT07227168

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2028-04-30

Brief Summary

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This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:

* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).
* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.
* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.

Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma HNSCC Non-Small Cell Lung Cancer NSCLC Esophageal Cancer Gastric Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma (PDAC) Cervical Cancer Endometrial Cancer Urothelial Cancer

Keywords

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Tissue Factor (TF) STRO-004 Antibody Drug Conjugate ADC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A STRO-004 Monotherapy

Group Type EXPERIMENTAL

STRO-004

Intervention Type DRUG

IV Infusion

Part 1B STRO-004 Monotherapy

Group Type EXPERIMENTAL

STRO-004

Intervention Type DRUG

IV Infusion

Part 1C STRO-004 in Combination with Pembrolizumab

Group Type EXPERIMENTAL

STRO-004

Intervention Type DRUG

IV Infusion

Pembrolizumab

Intervention Type DRUG

IV Infusion

Interventions

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STRO-004

IV Infusion

Intervention Type DRUG

Pembrolizumab

IV Infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies
* Availability of tumor tissue
* Measurable disease per RECIST 1.1
* Adequate organ function
* Participants receiving anticoagulants must be on a stable dose

Exclusion Criteria

* Eye disorders
* Untreated brain metastases
* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
* Previous solid organ or bone marrow transplantation
* Concurrent participation in another therapeutic treatment trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sutro Biopharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SCRI Denver

Denver, Colorado, United States

Site Status NOT_YET_RECRUITING

SCRI FCS Lake Mary

Lake Mary, Florida, United States

Site Status NOT_YET_RECRUITING

SCRI FCS Sarasota

Sarasota, Florida, United States

Site Status NOT_YET_RECRUITING

Mass General Cancer Center

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

NEXT Austin

Austin, Texas, United States

Site Status RECRUITING

NEXT San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sutro Clinical Development

Role: CONTACT

Phone: 650-801-6416

Email: [email protected]

Other Identifiers

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STRO-004-ST1

Identifier Type: -

Identifier Source: org_study_id