StrataPATH™ (Precision Indications for Approved Therapies)

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Strata Oncology
Study ID
NCT05097599
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumor
  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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

Study Details

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.

Key Dates

Start date
Apr 29, 2022
Status verified
Jan 2025
Primary completion
Jun 12, 2024
Completion
Jun 12, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Lorbrena® (lorlatinib)
  • Other: Braftovi® (encorafenib) + Mektovi® (binimetinib)
  • Other: Talzenna® (talazoparib)
  • Other: Trodelvy® (sacituzumab govitecan-hziy)
  • Other: Inlyta® (axitinib)
  • Other: Enhertu® (fam-trastuzumab deruxtecan-nxki)
  • Other: Padcev® (enfortumab vedotin)

Primary Outcome Measure

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists - NorthSt. PetersburgFlorida33705-
Florida Cancer Specialists - PanhandleTallahasseeFlorida32308-
Kettering Health NetworkKetteringOhio45429-
University of WisconsinMadisonWisconsin53792-

Find similar trials in St. Petersburg, FL

By research site
Florida Cancer Specialists - North· St. Petersburg, FLFlorida Cancer Specialists - Panhandle· Tallahassee, FLKettering Health Network· Kettering, OHUniversity of Wisconsin· Madison, WI

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