RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests STRO-004 alone or with pembrolizumab in adults with certain cancers that have spread or grown into nearby tissue. It looks at safety, finds doses for future studies, and checks whether treatment helps fight cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • Tests of tissue or cells show an eligible cancer: certain head and neck, lung, esophagus, stomach, colon, rectal, pancreatic, cervical, uterine lining, or urinary tract cancers.
  • You can do all usual activities, or only have trouble with hard physical activity.
  • You have received all suitable, locally available treatments that act throughout the body. Parts 1A and 1C have no limit on past treatments. Part 1B allows up to 3, or up to 4 for people with non-small cell lung cancer with certain gene changes.
  • A sample of your tumor tissue is available.
  • Your cancer can be measured using the study’s rules.
  • Your organs work well enough for the study.
  • If you take blood thinners, your dose must be stable.

Who can't join

  • You have an eye disorder.
  • Your cancer has spread to the brain and has not been treated there.
  • You have active interstitial lung disease, which affects tissue around the lungs’ air sacs.
  • You have serious heart disease, disease of blood vessels in the brain, or another serious health condition that is not controlled.
  • You have had an organ or bone marrow transplant.
  • You are taking part in another trial that gives treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (9)

CA

CO

DC

FL

MA

NY

TX

VA