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

Completed · Phase 2

Conditions studied: Advanced Unresectable or Metastatic Solid Malignancy

In brief

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.

Key facts

Study ID

NCT04632992

Run by

Genentech, Inc.

People needed

252

Starts

2021-01-13

Expected to finish

2024-02-27

Last updated by the study team

2025-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• In addition to the general inclusion criteria above, there are treatment-specific inclusion criteria that apply for each respective treatment arm (as detailed in the protocol)

You may not qualify if…

• 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
• Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
• Major surgical procedure, other than for diagnosis, or significant traumatic injury within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
• Pregnant or breastfeeding, or intending to become pregnant during the study
• In addition to the general exclusion criteria above, there are treatment-specific exclusion criteria that apply for each respective treatment arm (as detailed in the protocol)

Where it is running

• 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
• Eastern CT Hematology and Oncology Associates — Norwich, Connecticut, United States
• SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
• Florida Cancer Specialists - NORTH - SCRI - PPDS — St. Petersburg, Florida, United States
• Florida Cancer Specialists - PAN - SCRI - PPDS — Tallahassee, Florida, United States
• Florida Cancer Specialists - EAST - SCRI - PPDS — West Palm Beach, Florida, United States
• St Luke?s Cancer Institute — Boise, Idaho, United States
• Hematology and Oncology Clinic — Baton Rouge, Louisiana, United States
• Saint Agnes Hospital - Baltimore - Hunt - PPDS — Baltimore, Maryland, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Frontier Cancer Center and Blood Institute — Billings, Montana, United States
• Southeast Nebraska Cancer Center — Lincoln, Nebraska, United States
• New Jersey Hematology Oncology Associates LLC — Brick, New Jersey, United States
• Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States
• Central Park Hematology and Oncology — New York, New York, United States
• Eastchester Center for Cancer Care — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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