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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 : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE November 12, 2020
First Posted Date  ICMJE November 17, 2020
Last Update Posted Date April 12, 2021
Actual Study Start Date  ICMJE January 13, 2021
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
  • Duration of Response, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria [ Time Frame: Up to 4 years ]
  • Overall Survival [ Time Frame: Up to 4 years ]
  • 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) ]
  • 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) ]
  • 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 ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Unresectable or Metastatic Solid Malignancy
Intervention  ICMJE
  • 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
  • Drug: GDC-0077
    GDC-0077 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:
    • Inavolisib
    • RG6114
  • 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
  • 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
  • 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
  • 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
  • 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
  • Drug: Tucatinib
    Tucatinib 300 mg will be administered orally BID continuously starting from Cycle 1 Day 1 onwards.
    Other Name: Tukysa™
  • 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.
Study Arms  ICMJE
  • Experimental: Arm A: Entrectinib
    Participants in this treatment arm must have a positive biomarker result for ROS1 gene fusion.
    Intervention: Drug: Entrectinib
  • Experimental: Arm B: GDC-0077
    Participants in this treatment arm must have a positive biomarker result for PI3K activating mutations (PIK3CA).
    Intervention: Drug: GDC-0077
  • Experimental: Arm C: Alectinib
    Participants in this treatment arm must have a positive biomarker result for ALK rearrangement.
    Intervention: Drug: Alectinib
  • Experimental: Arm D: Ipatasertib
    Participants in this treatment arm must have a positive biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
    Intervention: Drug: Ipatasertib
  • Experimental: Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
    Participants in this treatment arm must have a positive biomarker result for either tumor mutational burden (TMB) high or microsatellite instability (MSI) high/deficient mismatch repair (dMMR).
    Interventions:
    • Drug: Atezolizumab
    • Drug: Investigator's Choice of Chemotherapy
  • Experimental: Arm F: Trastuzumab Emtansine + Atezolizumab
    Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Trastuzumab Emtansine
  • Experimental: Arm G: PH FDC SC
    Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
    Intervention: Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
  • Experimental: Arm H: PH FDC SC + Investigator's Choice of Chemotherapy
    Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
    Interventions:
    • Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
    • Drug: Investigator's Choice of Chemotherapy
  • Experimental: Arm I: Trastuzumab Emtansine + Tucatinib
    Participants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
    Interventions:
    • Drug: Trastuzumab Emtansine
    • Drug: Tucatinib
  • Experimental: Arm J: Trastuzumab Emtansine + Atezolizumab
    Participants in this treatment arm must have a positive biomarker results for ERBB2 mutation or amplification and TMB high or MSI high/dMMR.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Trastuzumab Emtansine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Whole brain 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04632992
Other Study ID Numbers  ICMJE ML42439
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).

Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP