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StrataPATH™ (Precision Indications for Approved Therapies)

NCT05097599 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-01-08

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Kat Kwiatkowski, PhD · Strata Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2024-06-12
Completion
2024-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097599 on ClinicalTrials.gov