Targeted Therapy for Cancer

(StrataPATH Trial)

Recruiting at 5 trial locations

Overseen By Kat Kwiatkowski

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Strata Oncology

Must not be taking: Cancer treatments

Disqualifiers: Second malignancy, CNS tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kat Kwiatkowski, PhD

Principal Investigator

Strata Oncology

Eligibility Criteria

Adults with confirmed solid tumors who can provide blood samples and have specific biomarkers as per the trial's requirements. They must be able to follow the study schedule, have adequate organ function, and not be pregnant or nursing. Excluded are those on other cancer treatments, recent major surgery patients, individuals with primary brain tumors or uncontrolled medical conditions.

Inclusion Criteria

My heart is strong, with a good ejection fraction and normal QTc interval.

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

My doctor says my organs and blood tests are good enough for treatment.

Exclusion Criteria

Receiving another cancer treatment

I have side effects from cancer treatment, but not nerve damage, that are moderate to severe.

I have a brain tumor.

Treatment Details

Interventions

• Encorafenib + Binimetinib
• Enfortumab Vedotin
• Enhertu
• Fam-Trastuzumab Deruxtecan-Nxki
• Lorlatinib
• PADCEV
• Talazoparib

Trial Overview The Strata PATH™ trial is testing the effectiveness of various FDA-approved cancer drugs like encorafenib + binimetinib and pembrolizumab in new patient groups identified by certain biomarkers. It's an open-label study where all participants know which treatment they're receiving.

Participant Groups

Group I: Trodelvy® (sacituzumab govitecan-hziy) Experimental Treatment 1 Intervention

Group II: Talzenna® (talazoparib) Experimental Treatment 1 Intervention

Group III: Padcev® (enfortumab vedotin) Experimental Treatment 1 Intervention

Group IV: Lorbrena® (lorlatinib) Experimental Treatment 1 Intervention

Group V: Inlyta® (axitinib) Experimental Treatment 1 Intervention

Group VI: Enhertu® (fam-trastuzumab deruxtecan-nxki) Experimental Treatment 1 Intervention

Group VII: Braftovi® (encorafenib) + Mektovi® (binimetinib) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Strata Oncology

Lead Sponsor

Trials

6

Recruited

58,700+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine