Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around
Principal Investigator
by Lyudmila Bazhenova, M.D.
Headshot of Lyudmila Bazhenova
Lyudmila Bazhenova

Description

Summary

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.

Official Title

A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors

Keywords

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, Tissue Factor (TF), STRO-004, Antibody Drug Conjugate, ADC, Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    San Diego California 92037 United States
  • SCRI Denver accepting new patients
    Denver Colorado 80218 United States

Lead Scientist at UCSD

  • Lyudmila Bazhenova, M.D.
    Dr. Bazhenova’s clinical practice and research concentrate on lung cancer, particularly as this relates to females and non-smokers. She actively participates in cooperative group trials, and takes an active role in designing and implementing clinical investigations, including phase II studies and correlative science projects with several UCSD investigators.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sutro Biopharma, Inc.
ID
NCT07227168
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated