StrataPATH™ (Precision Indications for Approved Therapies)

PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

April 29, 2022

Primary Completion Date

June 12, 2024

Study Completion Date

June 12, 2024

Conditions
CancerAdvanced Solid Tumor
Interventions
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.

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.

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.

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.

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.

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

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

Trial Locations (4)

32308

Florida Cancer Specialists - Panhandle, Tallahassee

33705

Florida Cancer Specialists - North, St. Petersburg

45429

Kettering Health Network, Kettering

53792

University of Wisconsin, Madison

Sponsors

Lead Sponsor

Collaborators (2)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

Gilead Sciences

INDUSTRY

lead

Strata Oncology

INDUSTRY