A Study of Targeted Genetics-Based Cancer Therapy for Solid Tumors (The "TAPISTRY" Study)

a study on Solid Tumor

Summary

Location
at Sacramento, California and other locations
Dates
study started
completion around

Description

Summary

TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.

Official Title

Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Keywords

Solid Tumors, Trastuzumab, Atezolizumab, Ado-Trastuzumab Emtansine, Maytansine, Ipatasertib, Pralsetinib, Alectinib, Entrectinib, Inavolisib, Trastuzumab emtansine, Idasanutlin, Belvarafenib, GDC-6036, Camonsertib, ROS1 Fusion-positive tumors (excluding NSCLC), NTRK1/2/3 fusion-positive tumors, ALK fusion-positive tumors (excluding NSCLC), TMB-high tumors, AKT1/2/3 mutant-positive tumors, HER2 mutant-positive tumors, MDM2-amplified, TP53 wild-type tumors, PIK3CA multiple mutant-positive tumors, BRAF class III mutant-positive tumors, RET fusion-positive tumors (excluding NSCLC), KRAS G12C-positive tumors (excluding NSCLC and CRC)

Eligibility

You can join if…

  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)

  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative

    Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years:

    Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%

  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort

You CAN'T join if...

  • Current participation or enrollment in another therapeutic clinical trial
  • Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
  • Whole brain radiotherapy within 14 days prior to start of study treatment
  • Stereotactic radiosurgery within 7 days prior to start of study treatment
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
  • 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
  • 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
  • History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy

  • In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific

    exclusion criteria

Locations

  • UC Davis Comprehensive Cancer Center terminated
    Sacramento California 95817 United States
  • University of California at San Francisco completed
    San Francisco California 94115 United States
  • USC Norris Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • St. Alphonsus accepting new patients
    Boise Idaho 83706 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
Links
Sign up for this study
ID
NCT04589845
Phase
Phase 2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 920 study participants
Last Updated
Contact us about this trial