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

Sutro Biopharma

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: Pembrolizumab; Drug: STRO-004

Study type: Interventional

Funder types: Industry

Identifiers

NCT07227168

STRO-004-ST1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Part 1A STRO-004 Monotherapy

Experimental group

Treatment:

Drug: STRO-004

Part 1B STRO-004 Monotherapy

Experimental group

Treatment:

Drug: STRO-004

Part 1C STRO-004 in Combination with Pembrolizumab

Experimental group

Treatment:

Drug: Pembrolizumab

Drug: STRO-004