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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

NCT04632992

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: ML42439
  • NCT ID: NCT04632992

Conditions

  • Advanced Unresectable or Metastatic Solid Malignancy

Interventions

DrugSynonymsArms
EntrectinibRozlytrek™, RG6268Arm A: Entrectinib
GDC-0077Inavolisib, RG6114Arm B: GDC-0077
AlectinibAlecensa®, RG7853Arm C: Alectinib
IpatasertibGDC-0068, RG7440Arm D: Ipatasertib
AtezolizumabTecentriq®, RG7446Arm E: Atezolizumab + Investigator's Choice of Chemotherapy
Trastuzumab EmtansineKadcyla®, RG3502Arm F: Trastuzumab Emtansine + Atezolizumab
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxfPhesgo™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264Arm G: PH FDC SC
TucatinibTukysaArm I: Trastuzumab Emtansine + Tucatinib
Investigator's Choice of ChemotherapyArm E: Atezolizumab + Investigator's Choice of Chemotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm A: EntrectinibExperimentalParticipants in this treatment arm must have a positive biomarker result for ROS1 gene fusion.
  • Entrectinib
Arm B: GDC-0077ExperimentalParticipants in this treatment arm must have a positive biomarker result for PI3K activating mutations (PIK3CA).
  • GDC-0077
Arm C: AlectinibExperimentalParticipants in this treatment arm must have a positive biomarker result for ALK rearrangement.
  • Alectinib
Arm D: IpatasertibExperimentalParticipants in this treatment arm must have a positive biomarker result for either AKT1/2/3 activating mutation or PTEN loss/loss of function.
  • Ipatasertib
Arm E: Atezolizumab + Investigator's Choice of ChemotherapyExperimentalParticipants 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).
  • Atezolizumab
  • Investigator's Choice of Chemotherapy
Arm F: Trastuzumab Emtansine + AtezolizumabExperimentalParticipants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
  • Atezolizumab
  • Trastuzumab Emtansine
Arm G: PH FDC SCExperimentalParticipants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
  • Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Arm H: PH FDC SC + Investigator's Choice of ChemotherapyExperimentalParticipants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
  • Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
  • Investigator's Choice of Chemotherapy
Arm I: Trastuzumab Emtansine + TucatinibExperimentalParticipants in this treatment arm must have a positive biomarker result for ERBB2 mutation or amplification without known TMB high or MSI high/dMMR.
  • Trastuzumab Emtansine
  • Tucatinib
Arm J: Trastuzumab Emtansine + AtezolizumabExperimentalParticipants in this treatment arm must have a positive biomarker results for ERBB2 mutation or amplification and TMB high or MSI high/dMMR.
  • Atezolizumab
  • Trastuzumab Emtansine

Eligibility 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, in order to be enrolled in a
             treatment arm of the study, patients must meet all of the treatment-specific inclusion
             criteria for the respective 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

          -  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 for each respective treatment arm (as detailed in the protocol)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:RANO = Response Assessment in Neuro-Oncology; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1

Secondary Outcome Measures

Measure:Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Duration of Response, as Determined by the Investigator According to RECIST v1.1 or RANO Criteria
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

November 17, 2020