Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04589845

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Solid Tumors

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by RECIST v1.1, RANO, or INRC
  • Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants 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

Exclusion criteria

  • 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

Treatment and study plan

Entrectinib

Drug

Adults and pediatric participants with a BSA ≥1.51 m^2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m^2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m^2) or 300 mg/day (BSA=0.81-1.10 m^2) or 200 mg/day (BSA=0.51-0.80 m^2) or 300 milligrams per square meter (mg/m^2) (BSA=0.43-0.50 m^2).

Other names: Rozlytrek

Alectinib

Drug

Alectinib will be administered orally BID with food at a dosage of 600 mg (four 150-mg capsules).

Other names: Alecensa

Atezolizumab

Drug

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged ≥18 years, and 15 mg/kg (maximum 1200 mg) for participants aged <18 years on Day 1 of each 21-day cycle.

Other names: Tecentriq

Ipatasertib

Drug

For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants < 35 kg, 300 mg for participants ≥35 and < 45 kg, 400 mg for those ≥ 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.

Trastuzumab Emtansine

Drug

Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.

Other names: Kadcyla

Inavolisib

Drug

GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.

Other names: GDC-0077

Belvarafenib

Drug

Belvarafenib will be administered at a dose 400 mg, PO, BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Pralsetinib

Drug

Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric participants ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Other names: Gavreto (US)

Divarasib

Drug

Divarasib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric participants. A treatment cycle consists of 3 weeks (21 days).

Other names: GDC-6036

Camonsertib

Drug

Camonsertib will be self-administered by participants orally at home (except on clinic days). A treatment cycle consists of 3 weeks and will be given on days 1-3 and days 8-10 of every 21-day cycle.

Primary outcomes

  1. All Cohorts: Independent Review Committee (IRC)-assessed Objective Response Rate (ORR) Based on Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Time frame: Approximately up to 12 years

    Confirmed objective response indicates ≥4 weeks after initial documentation of response.

Secondary outcomes

  1. All Cohorts: IRC-assessed Duration of Response (DOR) per RECIST v1.1

    Time frame: Approximately up to 12 years

  2. All Cohorts: IRC-assessed Clinical Benefit Rate (CBR) per RECIST v1.1

    Time frame: Approximately up to 12 years

  3. All Cohorts: IRC-assessed Progression-free Survival (PFS) per RECIST v1.1

    Time frame: Approximately up to 12 years

  4. All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1

    Time frame: Approximately up to 12 years

  5. All Cohorts: INV-assessed DOR per RECIST v1.1

    Time frame: Approximately up to 12 years

  6. All Cohorts: INV-assessed CBR per RECIST v1.1

    Time frame: Approximately up to 12 years

  7. All Cohorts: INV-assessed PFS per RECIST v1.1

    Time frame: Approximately up to 12 years

  8. All Cohorts: IRC- and INV-assessed Time to Central Nervous System (CNS) Progression per RECIST v1.1

    Time frame: Approximately up to 12 years

  9. All Cohorts: Overall Survival (OS)

    Time frame: Approximately up to 12 years

  10. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-oncology (RANO)

    Time frame: Approximately up to 12 years

  11. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO

    Time frame: Approximately up to 12 years

  12. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO

    Time frame: Approximately up to 12 years

  13. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO

    Time frame: Approximately up to 12 years

  14. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO

    Time frame: Approximately up to 12 years

  15. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO

    Time frame: Approximately up to 12 years

  16. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO

    Time frame: Approximately up to 12 years

  17. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO

    Time frame: Approximately up to 12 years

  18. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)

    Time frame: Approximately up to 12 years

  19. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed DOR per INRC

    Time frame: Approximately up to 12 years

  20. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed CBR per INRC

    Time frame: Approximately up to 12 years

  21. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed PFS per INRC

    Time frame: Approximately up to 12 years

  22. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed ORR per INRC

    Time frame: Approximately up to 12 years

  23. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed DOR per INRC

    Time frame: Approximately up to 12 years

  24. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed CBR per INRC

    Time frame: Approximately up to 12 years

  25. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed PFS per INRC

    Time frame: Approximately up to 12 years

  26. Cohorts A, B, C, D, I, J, K: IRC-assessed Intracranial (IC)-ORR per RECIST v1.1

    Time frame: Approximately up to 12 years

  27. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1

    Time frame: Approximately up to 12 years

  28. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1

    Time frame: Approximately up to 12 years

  29. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS Rate per RECIST v1.1

    Time frame: Approximately up to 12 years

  30. Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1

    Time frame: Approximately up to 12 years

  31. Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1

    Time frame: Approximately up to 12 years

  32. Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1

    Time frame: Approximately up to 12 years

  33. Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS Rate per RECIST v1.1

    Time frame: Approximately up to 12 years

  34. Cohorts A, B and F: Percentage of Participants With Confirmed Deterioration as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Time frame: Approximately up to 12 years

    The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.

  35. Cohorts A, B and F: Change From Baseline in the EORTC-QLQ-C30 Total Score

    Time frame: Approximately up to 12 years

    The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.

  36. Cohorts A, B and F: Percentage of Participants With a Clinical Meaningful Change on the Global Health Status, Physical Functioning, and Role Functioning Scores From the EORTC QLQ-C30

    Time frame: Approximately up to 12 years

    The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.

  37. Cohorts A, B and F: Time to Confirmed Symptom Onset or Worsening From Tumor-related Symptom Scores From the EORTC QLQ-C30 and EORTC Item Library 71 (IL71)

    Time frame: Approximately up to 12 years

    The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.

  38. All Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Approximately up to 12 years

    AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)

  39. Cohort F: Serum Concentration of Trastuzumab Emtansine at Specified Timepoints

    Time frame: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (up to approximately 25 months) (one Cycle=21 days)

  40. Cohort F: Percentage of Participants with Anti-drug Antibodies (ADA)

    Time frame: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (up to approximately 25 months) (one Cycle=21 days)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Important dates

Study start
2021
Primary completion
2032
Study completion
2032
First posted
Oct 19, 2020
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.