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

Advanced Unresectable or Metastatic Solid Malignancy Clinical Trial

— MyTACTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632992
• Other study ID #: ML42439
• Status: Completed
• Phase: Phase 2
• Start date: January 13, 2021
• Est. completion date: February 27, 2024

Study information

• Verified date: March 2024
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: February 27, 2024
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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)

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

• 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)

Related Conditions & MeSH terms

• Advanced Unresectable or Metastatic Solid Malignancy
• Neoplasms

Intervention

Drug:
• Entrectinib
Entrectinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 600 milligrams (mg) per day once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.
• Inavolisib
Inavolisib will be self-administered by participants orally at home (except on clinic days) at the same time each day, on a starting dose of 9 mg/day QD until disease progression, intolerable toxicity, or consent withdrawal.
• Alectinib
Alectinib will be self-administered by participants orally at home (except on clinic days), at the same times each day, on a starting dose of 600 mg twice a day (BID) until disease progression, intolerable toxicity, or consent withdrawal.
• Ipatasertib
Ipatasertib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg QD until disease progression, intolerable toxicity, or consent withdrawal.
• Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg for participants on Day 1 of each 21-day cycle until unacceptable toxicity or progressive disease (or loss of clinical benefit).
• Trastuzumab Emtansine
Trastuzumab emtansine will be administered at 3.6 mg per kilogram (kg) of body weight by IV infusion every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
• Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab once every 3 weeks.
• Tucatinib
Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
• Investigator's Choice of Chemotherapy
Chemotherapy will consist of docetaxel, paclitaxel, or capecitabine, as determined by the investigator, and will be administered per the respective package insert and institutional guidelines.
• Paclitaxel
The dose of paclitaxel is 80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. The paclitaxel infusion will be delivered over at least 60 minutes for each dose per institutional guidelines and administered after the oral dose of ipatasertib.
• Tiragolumab
Following the administration of atezolizumab and an observation period, participants will receive 600 mg tiragolumab at a fixed dose administered by IV infusion on Day 1 of each 21-day cycle.
• Pralsetinib
Pralsetinib will be self-administered by participants orally at home (except on clinic days), at the same time each day, on a starting dose of 400 mg/day (four 100-mg capsules per day) once a day (QD) until disease progression, intolerable toxicity, or consent withdrawal.

Locations

Country	Name	City	State
United States	Alaska Oncology and Hematology	Anchorage	Alaska
United States	Messino Cancer Centers	Asheville	North Carolina
United States	Saint Agnes Hospital - Baltimore - Hunt - PPDS	Baltimore	Maryland
United States	Hematology and Oncology Clinic	Baton Rouge	Louisiana
United States	Frontier Cancer Center and Blood Institute	Billings	Montana
United States	St Luke?s Cancer Institute	Boise	Idaho
United States	New Jersey Hematology Oncology Associates LLC	Brick	New Jersey
United States	Eastchester Center for Cancer Care	Bronx	New York
United States	Gabrail Cancer Center	Canton	Ohio
United States	Tri County Hematologyoncology	Canton	Ohio
United States	SCRI Tennessee Oncology Chattanooga	Chattanooga	Tennessee
United States	SCRI Mark H. Zangmeister Center	Columbus	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Astera Cancer Care East Brunswick	East Brunswick	New Jersey
United States	California Cancer Associates for Research and Excellence - Encinitas	Encinitas	California
United States	Northwest Medical Specialties B	Federal Way	Washington
United States	SCRI Florida Cancer Specialists South	Fort Myers	Florida
United States	The Center for Cancer and Blood Disorders - PPDS	Fort Worth	Texas
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	The West Clinic, PC dba West Cancer Center	Memphis	Tennessee
United States	Pacific Cancer Care - Monterey	Monterey	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Central Park Hematology and Oncology	New York	New York
United States	Eastern CT Hematology and Oncology Associates	Norwich	Connecticut
United States	Arizona Clinical Research Ctr	Oro Valley	Arizona
United States	Kaiser Permanente Center For Health Research	Portland	Oregon
United States	Virginia Commonwealth University - Massey Cancer Center	Richmond	Virginia
United States	Kaiser Permanente - Sacramento Medical Center and Medical Offices	Sacramento	California
United States	Florida Cancer Specialists - NORTH - SCRI - PPDS	Saint Petersburg	Florida
United States	Mays Cancer Center at UT Health San Antonio MD Anderson Cancer	San Antonio	Texas
United States	Kaiser Permanente - San Francisco Medical Center	San Francisco	California
United States	Kaiser Permanente - San Jose Medical Center	San Jose	California
United States	Kaiser Permanente - San Leandro Medical Center	San Leandro	California
United States	California Cancer Associates for Research & Excellence, Inc.	San Marcos	California
United States	Kaiser Permanente - Santa Clara	Santa Clara	California
United States	Sarcoma Oncology Center	Santa Monica	California
United States	New York Cancer & Blood Specialists	Shirley	New York
United States	Kaiser Permanente - South San Francisco	South San Francisco	California
United States	Florida Cancer Specialists - PAN - SCRI - PPDS	Tallahassee	Florida
United States	Kaiser Permanente Medical Ctr	Vallejo	California
United States	Ventura County Hematology Oncology Specialists	Ventura	California
United States	K. Permanente - Walnut Creek	Walnut Creek	California
United States	Florida Cancer Specialists - EAST - SCRI - PPDS	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Confirmed Overall Response, as Assessed by the Investigator According to RECIST v1.1 or According to RANO Criteria for Primary CNS Tumors	RANO = Response Assessment in Neuro-Oncology; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1	Up to 3 years
Secondary	Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria		Up to 3 years
Secondary	Duration of Response, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria		Up to 3 years
Secondary	Progression-Free Survival Rate at Every 3 Months, Defined as the Percentage of Participants who are Progression-Free as Determined by the Investigator According to RECIST v1.1 or RANO Criteria		At every 3 months until study completion (up to 3 years)
Secondary	Percentage of Participants with Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria		Up to 3 years
Secondary	Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)		From Baseline until 28 days after the final dose of study drug (up to 3 years)