StrataPATH™ (Precision Indications for Approved Therapies)

NCT05097599 | Terminated Phase 2 FDA Drug

• 2 other identifiers: STR-004-001KEYNOTE-F04
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer; Advanced Solid Tumor

Keywords

Cancer; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (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

  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 Outcomes (7)

• Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease

  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

  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.

  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

  6 months

• Overall Survival (OS)

  Assessed throughout end of study, up to 5 years

Other Outcomes (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.

  Assessed throughout end of study, up to 5 years

Study Arms (7)

Lorbrena® (lorlatinib)

OTHER

Drug: lorlatinib

Braftovi® (encorafenib) + Mektovi® (binimetinib)

OTHER

Drug: encorafenib + binimetinib

Talzenna® (talazoparib)

OTHER

Drug: talazoparib

Trodelvy® (sacituzumab govitecan-hziy)

OTHER

Drug: sacituzumab govitecan

Inlyta® (axitinib)

OTHER

Drug: axitinib

Enhertu® (fam-trastuzumab deruxtecan-nxki)

OTHER

Drug: Fam-Trastuzumab Deruxtecan-Nxki

Padcev® (enfortumab vedotin)

OTHER

Drug: enfortumab vedotin

Interventions

lorlatinib DRUG

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.

Lorbrena® (lorlatinib)

encorafenib + binimetinib DRUG

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.

Braftovi® (encorafenib) + Mektovi® (binimetinib)

talazoparib DRUG

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.

Talzenna® (talazoparib)

sacituzumab govitecan DRUG

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.

Trodelvy® (sacituzumab govitecan-hziy)

axitinib DRUG

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.

Inlyta® (axitinib)

Fam-Trastuzumab Deruxtecan-Nxki DRUG

This arm of the Strata PATH trial will assess the clinical benefit of Enhertu ® in patients with advanced solid tumors with Her2 overexpression

Also known as: Enhertu

Enhertu® (fam-trastuzumab deruxtecan-nxki)

enfortumab vedotin DRUG

This arm of the Strata PATH trial will assess the clinical benefit of Padcev® in patients with advanced solid tumors with nectin-4 overexpression

Also known as: Padcev

Padcev® (enfortumab vedotin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Strata Oncology: lead
• Merck Sharp & Dohme LLC: collaborator
• Pfizer: collaborator
• Gilead Sciences: collaborator

Study Sites (4)

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists - Panhandle

Tallahassee, Florida, 32308, United States

Location

Kettering Health Network

Kettering, Ohio, 45429, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

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Related Links

• American Cancer Society Cancer Statistics Center, 2020 9/4/2020
• U.S. Food and Drug Administration, FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. 2017.
• Merck, Merck's KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery, in Press Release. 2021.
• Temple, R., A regualtory authority's opinion about surrogate endpoints, in Clinical Measurement in Drug Evaluation, W.T. Nimmo, Editor. 1995, J.Wiley: New York.
• U.S. Food and Drug Administration, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry. 2018.
• U.S. Food and Drug Administration, FDA approves larotrectinib for solid tumors with NTRK gene fusions. 2018.

MeSH Terms

Conditions

Neoplasms

Interventions

lorlatinib; encorafenib; binimetinib; talazoparib; sacituzumab govitecan; Axitinib; enfortumab vedotin

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kat Kwiatkowski, PhD

  Strata Oncology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 28, 2021
• Study Start: April 29, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)