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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)

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ClinicalTrials.gov Identifier: NCT04632992
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Advanced Unresectable or Metastatic Solid Malignancy Drug: 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Arm A: Entrectinib
Participants in this treatment arm must have a positive tumor biomarker result for ROS1 gene fusion.
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.
Other Names:
  • Rozlytrek™
  • RG6268
  • RO7102122

Experimental: Arm B: Inavolisib
Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation.
Drug: 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.
Other Names:
  • GDC-0077
  • RG6114
  • RO7113755

Experimental: Arm C: Alectinib
Participants in this treatment arm must have a positive tumor biomarker result for ALK rearrangement tumors.
Drug: 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.
Other Names:
  • Alecensa®
  • RG7853
  • RO5424802

Experimental: Arm D: Ipatasertib
Participants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
Drug: 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.
Other Names:
  • GDC-0068
  • RG7440
  • RO5532961

Experimental: Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
Participants in this treatment arm must have a positive tumor biomarker result for either tumor mutational burden (TMB) high or microsatellite instability (MSI) high/deficient mismatch repair (dMMR).
Drug: 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).
Other Names:
  • Tecentriq®
  • RG7446
  • RO5541267

Drug: 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.

Experimental: Arm F: Trastuzumab Emtansine + Atezolizumab
Participants in this treatment arm must have a positive tumor biomarker result for ERBB2 mutations or amplification without known TMB high or MSI high/dMMR.
Drug: 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).
Other Names:
  • Tecentriq®
  • RG7446
  • RO5541267

Drug: 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.
Other Names:
  • Kadcyla®
  • RG3502
  • RO5304020

Experimental: Arm G: PH FDC SC
Participants in this treatment arm must have a positive tumor biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
Drug: 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.
Other Names:
  • PHESGO™
  • PH FDC SC
  • Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously
  • RG6264
  • RO7198574

Experimental: Arm H: PH FDC SC + Investigator's Choice of Chemotherapy
Participants in this treatment arm must have a positive tumor biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
Drug: 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.
Other Names:
  • PHESGO™
  • PH FDC SC
  • Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously
  • RG6264
  • RO7198574

Drug: 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.

Experimental: Arm I: Trastuzumab Emtansine + Tucatinib
Participants in this treatment arm must have a positive tumor biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
Drug: 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.
Other Names:
  • Kadcyla®
  • RG3502
  • RO5304020

Drug: Tucatinib
Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
Other Name: Tukysa™

Experimental: Arm J: Trastuzumab Emtansine + Atezolizumab
Participants in this treatment arm must have positive tumor biomarker results for ERBB2 mutation or amplification and TMB high or MSI high/dMMR.
Drug: 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).
Other Names:
  • Tecentriq®
  • RG7446
  • RO5541267

Drug: 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.
Other Names:
  • Kadcyla®
  • RG3502
  • RO5304020

Experimental: Arm K: Ipatasertib + Atezolizumab
Participants in this treatment arm must have a positive tumor biomarker result for PI3KCA activating mutation.
Drug: 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.
Other Names:
  • GDC-0068
  • RG7440
  • RO5532961

Drug: 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).
Other Names:
  • Tecentriq®
  • RG7446
  • RO5541267

Experimental: Arm L: Ipatasertib + Atezolizumab
Participants in this treatment arm must have a positive tumor biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
Drug: 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.
Other Names:
  • GDC-0068
  • RG7440
  • RO5532961

Drug: 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).
Other Names:
  • Tecentriq®
  • RG7446
  • RO5541267

Experimental: Arm M: Ipatasertib + Paclitaxel
Participants in this treatment arm must have a positive tumor biomarker results for PI3KCA activating mutations and either AKT1/2/3 activating mutation or PTEN loss/loss of function.
Drug: 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.
Other Names:
  • GDC-0068
  • RG7440
  • RO5532961

Drug: 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.

Experimental: Arm N: Atezolizumab + Tiragolumab
Participants in this treatment arm must have a positive tumor biomarker result for either TMB high or MSI high/dMMR.
Drug: 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).
Other Names:
  • Tecentriq®
  • RG7446
  • RO5541267

Drug: 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.
Other Names:
  • RG6058
  • RO7092284
  • MTIG7192A

Experimental: Arm O: Pralsetinib
Participants in this treatment arm must have a positive tumor biomarker result for RET fusion.
Drug: 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.
Other Names:
  • GAVRETO™
  • RG6396
  • RO7499790




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 4 years ]
    RANO = Response Assessment in Neuro-Oncology; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1


Secondary Outcome Measures :
  1. Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
  2. Duration of Response, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
  3. Overall Survival [ Time Frame: Up to 4 years ]
  4. 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 [ Time Frame: At every 3 months until study completion (up to 4 years) ]
  5. Overall Survival Rate at Every 3 Months, Defined as the Percentage of Participants who are Alive [ Time Frame: At every 3 months until study completion (up to 4 years) ]
  6. Percentage of Participants with Disease Control, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
  7. 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) [ Time Frame: From Baseline until 28 days after the final dose of study drug (up to 4 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632992


Contacts
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Contact: Reference Study ID Number: ML42439 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04632992    
Other Study ID Numbers: ML42439
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Maytansine
Ado-Trastuzumab Emtansine
Trastuzumab
Atezolizumab
Pertuzumab
Tucatinib
Pralsetinib
Entrectinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors