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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1A STRO-004 Monotherapy
  • Drug: STRO-004
    IV Infusion
Experimental
Part 1B STRO-004 Monotherapy
  • Drug: STRO-004
    IV Infusion
Experimental
Part 1C STRO-004 in Combination with Pembrolizumab
  • Drug: STRO-004
    IV Infusion
  • Drug: Pembrolizumab
    IV Infusion

Recruiting Locations

SCRI Denver
Denver 5419384, Colorado 5417618 80218
Contact:
Jessica Ellis
720-754-2610
Jessica.Ellis@SarahCannon.com

SCRI FCS Lake Mary
Lake Mary 4161373, Florida 4155751 32746
Contact:
Aimee Jackson
407-804-6133
ajackson@flcancer.com

SCRI FCS Sarasota
Sarasota 4172131, Florida 4155751 34232
Contact:
Sarah Gwirtz
941-377-9993
Sarah.Gwirtz@flcancer.com

NEXT Austin
Austin 4671654, Texas 4736286 78758
Contact:
Kayla Grossi
737-610-5200
kgrossi@nextoncology.com

NEXT San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Kayla Grossi
210-580-9511
kgrossi@nextoncology.com

NEXT Virginia
Fairfax 4758023, Virginia 6254928 22031
Contact:
Kayla Grossi
703-783-4510
kgrossi@nextoncology.com

More Details

Status
Recruiting
Sponsor
Sutro Biopharma, Inc.

Study Contact

Sutro Clinical Development
650-801-6416
ClinicalTrials@sutrobio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.