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Strata PATH™ (Precision Indications for Approved Therapies) (Strata PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05097599
Recruitment Status : Recruiting
First Posted : October 28, 2021
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
Strata Oncology

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Advanced Solid Tumor Drug: lorlatinib Drug: encorafenib + binimetinib Drug: talazoparib Drug: fam-trastuzumab deruxtecan-nxki Drug: enfortumab vedotin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strata PATH™ (Precision Indications for Approved Therapies): A Study Evaluating the Clinical Activity and Safety of Approved Drugs Within Biomarker-Guided Patients With Solid Tumors
Actual Study Start Date : November 19, 2021
Estimated Primary Completion Date : November 19, 2026
Estimated Study Completion Date : November 19, 2029
Arms and Interventions
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Arm Intervention/treatment
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.
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.
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.
Enhertu® (fam-trastuzumab deruxtecan-nxki) Drug: fam-trastuzumab deruxtecan-nxki
This arm of the Strata PATH trial will assess the clinical benefit of Enhertu® (fam-trastuzumab deruxtecan-nxki) in patients with advanced solid tumors harboring HER2 over-expression, as detected by Strata testing, excluding breast and gastric cancer.
Padcev® (enfortumab-vedotin) Drug: enfortumab vedotin
This arm of the StrataPATH trial will assess the clinical benefit of Padcev® (enfortumab-vedotin) in patients with advanced solid tumors harboring Nectin-4 over-expression, as detected by Strata testing, excluding urothelial cancer.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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


Other Outcome Measures:
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue or historical CGP or RNA profiling test results available for submission
  5. Biomarker positive for the defined cohort
  6. For individuals with treated or stable brain metastases: No 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
  8. Adequate cardiac function: 8.1) Left ventricular ejection fraction (LVEF) ≥ 50%, 8.2) 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. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment
  5. Ongoing toxicity of CTCAE grade ≥2, other than peripheral neuropathy, related to cancer treatment that was completed within 4 weeks of consent
  6. Ongoing peripheral neuropathy of CTCAE grade ≥3
  7. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent
  8. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection
  9. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
  10. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05097599


Contacts
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Contact: Stephanie Bush (734) 527-1000 stephanie.bush@strataoncology.com
Contact: Melissa Wolfe (734) 527-1000 melissa.wolfe@strataoncology.com

Locations
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United States, Arkansas
Genesis Cancer and Blood Institute Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Strata Oncology    734-527-1000      
United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19713
Contact: Strata Oncology    734-527-1000      
United States, Florida
Florida Cancer Specialists - South Recruiting
Fort Myers, Florida, United States, 33901
Contact: Strata Oncology    734-527-1000      
Florida Cancer Specialists - North Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Strata Oncology    734-527-1000      
Florida Cancer Specialists - Panhandle Recruiting
Tallahassee, Florida, United States, 32308
Contact: Strata Oncology    734-527-1000      
Florida Cancer Specialists - East Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Strata Oncology    734-527-1000      
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Strata Oncology    734-527-1000      
United States, Louisiana
Hematology Oncology Clinic - Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Strata Oncology    734-527-1000      
United States, Ohio
Zangmeister Cancer Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Strata Oncology    734-527-1000      
Kettering Health Network Recruiting
Kettering, Ohio, United States, 45429
Contact: Strata Oncology    734-527-1000      
United States, Tennessee
Tennessee Oncology - Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Strata Oncology    734-527-1000      
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Strata Oncology    734-527-1000      
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Strata Oncology    734-527-1000      
Sponsors and Collaborators
Strata Oncology
Investigators
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Study Director: Kat Kwiatkowski, PhD Strata Oncology
More Information
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Additional Information:

Publications:

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Responsible Party: Strata Oncology
ClinicalTrials.gov Identifier: NCT05097599    
Other Study ID Numbers: STR-004-001
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Strata Oncology:
Cancer
Advanced Solid Tumor
Additional relevant MeSH terms:
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Trastuzumab
Talazoparib
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action