StrataPATH™ (Precision Indications for Approved Therapies) (StrataPATH)

January 6, 2025 updated by: Strata Oncology

StrataPATH™ (Precision Indications for Approved Therapies): A Study Evaluating the Clinical Activity and Safety of Approved Drugs Within Biomarker-Guided Patients With Solid Tumors

StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations. Aiming to increase clinical benefit for patients, this study will leverage technology advancements, scientific literature, and Strata's real-world evidence to define novel, highly responsive pan-tumor molecular indications for FDA-approved therapies in both the advanced and micro-metastatic settings. Strata will rapidly identify participants who have efficacy signals for possible expansion into adaptive or randomized studies. Enrollment in each drug/biomarker cohort is competitive. Cohorts may be added, changed, or discontinued over the course of the study

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists - North
      • Tallahassee, Florida, United States, 32308
        • Florida Cancer Specialists - Panhandle
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Health Network
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

To be eligible to participate in this study, an individual must meet each of the criterion below and the criteria indicated in the selected biomarker/drug cohort appendix:

  1. Male or female ≥18 years of age.
  2. Pathologically confirmed solid tumor
  3. Participants must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
  4. CGP results need to be from a test conducted in a CLIA approved laboratory and archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue is required for confirmatory testing of non-Strata test results unless otherwise indicated within the cohort-specific protocol criteria.
  5. Biomarker positive for the defined cohort
  6. For individuals with non-primary, treated or stable brain metastases: No evidence of progression (defined as no radiographic evidence of progression) for at least 4 weeks prior to consent.
  7. Adequate bone marrow, organ function & laboratory parameters as determined by the treating physician unless otherwise indicated within the cohort-specific protocol criteria.
  8. Adequate cardiac function: 1) Left ventricular ejection fraction (LVEF) ≥ 50% and 2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred.

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Receiving another cancer treatment
  2. Major surgery within 4 weeks prior to study entry
  3. Has received a systemic cancer treatment within 3 weeks of first study dose
  4. Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study principal investigator to determine eligibility.
  5. Participant has primary central nervous system tumor.
  6. A woman of childbearing potential who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  7. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment.
  8. Ongoing toxicity of CTCAE grade >2, other than peripheral neuropathy, related to anticancer therapy that was completed within 4 weeks of consent.
  9. Ongoing peripheral neuropathy of CTCAE grade >3.
  10. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent.
  11. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection.
  12. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder.
  13. Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lorbrena® (lorlatinib)
Drug: lorlatinib
This arm of the Strata PATH trial will assess the clinical benefit of Lorbrena® (lorlatinib) in ALK and ROS1 gene fusion positive solid tumors, as detected by Strata testing, with the exception of NSCLC.
Other: Braftovi® (encorafenib) + Mektovi® (binimetinib)
Drug: encorafenib + binimetinib
This arm of the Strata PATH trial will assess the clinical benefit of Braftovi® (encorafenib) + Mektovi® (binimetinib) in BRAF p.v600X mutated solid tumors, as detected by Strata testing, with the exception of melanoma and colorectal cancer.
Other: Talzenna® (talazoparib)
Drug: talazoparib
This arm of the Strata PATH trial will assess the clinical benefit of Talzenna® (talazoparib) in patients with advanced solid tumors harboring deep deletions or deleterious mutations with LOH in BRCA1/2 and PALB2, as detected by Strata testing, excluding HER2 negative breast cancer.
Other: Enhertu® (fam-trastuzumab deruxtecan-nxki)
Drug: Fam-Trastuzumab Deruxtecan-Nxki
This arm of the Strata PATH trial will assess the clinical benefit of Enhertu ® in patients with advanced solid tumors with Her2 overexpression
Other Names:
  • Enhertu
Other: Trodelvy® (sacituzumab govitecan-hziy)
Drug: sacituzumab govitecan
This arm of the Strata PATH trial will assess the clinical benefit of Trodelvy® (sacituzumab govitecan) in patients with advanced solid tumors and are Trop2 Treatment Response Score High (Trop2 TRS-H), as detected by Strata testing, excluding triple negative breast cancer, hormone receptor positive/ human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer, metastatic urothelial cancer, non-small cell lung (NSCLC) cancer, small cell lung cancer (SCLC), head and neck cancer, colorectal cancer (CRC), and endometrial cancer.
Other: Inlyta® (axitinib)
Drug: axitinib
This arm of the Strata PATH trial will assess the clinical benefit of Inlyta® (axitinib) in patients with advanced solid tumors and are Angiogensis Inhibitor Treatment Response Score High (Angio TRS-H), as detected by Strata testing, excluding renal cell carcinoma, alveolar soft part sarcoma, and solitary fibrous tumors.
Other: Padcev® (enfortumab vedotin)
Drug: enfortumab vedotin
This arm of the Strata PATH trial will assess the clinical benefit of Padcev® in patients with advanced solid tumors with nectin-4 overexpression
Other Names:
  • Padcev

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) defined as the percentage of participants with a best overall response of CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the investigator
Time Frame: Assessed throughout end of study, up to 5 years
RECIST criteria will be used to assess the clinical activity of cancer treatments in participants with pre-specified biomarker profiles.
Assessed throughout end of study, up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease
Time Frame: Assessed throughout end of study, up to 5 years
DoR will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
Assessed throughout end of study, up to 5 years
Time to Treatment Discontinuation (TTD) defined as length of time from the date the participant initiates the systemic treatment to the date the participant discontinues treatment as compared to prior TTD from prior cancer treatment
Time Frame: Assessed throughout end of study, up to 5 years
TTD will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
Assessed throughout end of study, up to 5 years
TTnT (Time to Next Treatment) defined as the length of time from the date the participant initiates study treatment to the date the participant initiates their next systemic treatment or death.
Time Frame: Assessed throughout end of study, up to 5 years
TTnT will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
Assessed throughout end of study, up to 5 years
ctDNA Response Rate
Time Frame: Assessed throughout end of study, up to 5 years
Evaluate ctDNA response rate at additional timepoints for participants who received cancer treatment with pre-specified biomarker profiles
Assessed throughout end of study, up to 5 years
Overall Survival (OS)
Time Frame: Assessed throughout end of study, up to 5 years
Evaluate overall survival (OS) for participants who received a cancer treatment with pre-specified biomarker profiles
Assessed throughout end of study, up to 5 years
Incidence of serious adverse events (SAEs)
Time Frame: Assessed throughout end of study, up to 5 years
Monitor and summarize any unexpected safety events in participants who received a biomarker-guided cancer treatment
Assessed throughout end of study, up to 5 years
ctDNA response: The proportion of participants with a <50% ratio of mean variant allele frequency (VAF) will be defined as ctDNA responders
Time Frame: 6 months
Molecular response calculated as a ratio of mean VAF on treatment at 6 months compared to baseline VAF will be used to assess the clinical activity of cancer treatments in participants with pre-specified biomarker profiles.
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Explore the correlation between serial ctDNA levels over time and participant response to cancer therapy based on RECIST 1.1, as assessed by the investigator.
Time Frame: Assessed throughout end of study, up to 5 years
Assessed throughout end of study, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Strata Oncology

Collaborators

Merck Sharp & Dohme LLC
Pfizer
Gilead Sciences

Investigators

  • Study Director: Kat Kwiatkowski, PhD, Strata Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Actual)

June 12, 2024

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR-004-001
  • KEYNOTE-F04 (Other Identifier: Merck Sharp & Dohme, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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