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A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response | Clinical Trials | Clareo Health

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A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

NCT04632992•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers. Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic solid malignancy
•Positive biomarker results from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory and availability of a full report of the testing results. This may be from a tissue or blood sample.
•Evaluable or measurable disease
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
•Life expectancy ≥8 weeks
•Adequate hematologic and end-organ function, as defined in the protocol, obtained within 14 days prior to initiation of study treatment
•Agrees to take measures to prevent pregnancy in the patient or partner

Exclusion Criteria

•Current participation or enrollment in another therapeutic clinical trial
•Symptomatic or actively progressing CNS metastases (asymptomatic patients with treated or untreated CNS metastases may be eligible, provided all protocol-defined criteria are met)
•History of leptomeningeal disease, unless noted otherwise for a specific treatment arm of the study
•Wide field radiotherapy within 14 days prior to start of study treatment
•Stereotactic radiosurgery within 7 days prior to start of study treatment
•Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact patient safety
•Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1 (androgen blockage may be continued for male patients with prostate cancer)
•Known human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection with status outside of study-allowed criteria
•History of or concurrent serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
•History of malignancy other than disease under study within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
+4 more criteria

Locations (38)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Arizona Clinical Research Ctr

Oro Valley, Arizona, United States

Genesis Cancer Center

Hot Springs, Arkansas, United States

California Cancer Associates for Research and Excellence - Encinitas

Encinitas, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Pacific Cancer Care - Monterey

Monterey, California, United States

Kaiser Permanente - San Francisco Medical Center

San Francisco, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

Kaiser Permanente Medical Ctr

Vallejo, California, United States

Ventura County Hematology Oncology Specialists

Ventura, California, United States

Key Dates

Start Date

January 13, 2021

Primary Completion Date

December 4, 2023

Completion Date

February 27, 2024

Last Updated

January 8, 2025

Enrollment

252

ACTUAL participants

Conditions

Advanced Unresectable or Metastatic Solid Malignancy

Interventions

Entrectinib

DRUG

Inavolisib

DRUG

Alectinib

DRUG

Ipatasertib

DRUG

Atezolizumab

DRUG

Trastuzumab Emtansine

DRUG

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf

DRUG

Tucatinib

DRUG

Investigator's Choice of Chemotherapy

DRUG

Paclitaxel

DRUG

Tiragolumab

DRUG

Pralsetinib

DRUG