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Kinase Inhibitor

Targeted Therapy for Cancer (Strata PATH Trial)

Phase 2

Waitlist Available

Research Sponsored by Strata Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate cardiac function: 1) Left ventricular ejection fraction (LVEF) ≥ 50% and 2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred

Biomarker positive for the defined cohort

Must not have

Participant has primary central nervous system tumor

Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed throughout end of study, up to 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is exploring how well different cancer therapies work in new patient populations that have been identified using biomarkers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions typical for cancer therapies such as fatigue, nausea, skin reactions, changes in blood counts leading to increased infection risk or bleeding tendencies, potential heart issues (like altered heart rhythms), and possibly liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My condition matches the specific biomarker for this study.

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My cancer is a solid tumor confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain tumor.

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I have a history of HIV or Hepatitis B/C.

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I do not have severe numbness or pain in my hands or feet.

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I am not pregnant, nursing, or planning to become pregnant and will use contraception during treatment.

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I have not had a stroke, TIA, or heart attack in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed throughout end of study, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed throughout end of study, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed throughout end of study, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Incidence of serious adverse events (SAEs)

Overall Survival (OS)

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