MC# 20-26 - Tumor-Agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
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Agent(s): GDC-0077, Alectinib, Entrectinib, Atezolizumab, Pralsetinib, Belvarafenib
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Disease Type(s): Solid Tumor
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Phase(s): II
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Drug Classification(s): Monoclonal Antibody, Small Molecule, Targeted Therapy, Antibody Drug Conjugate
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Molecular Target(s): AKT, ALK, BRAF, PD-L1 (CD274), PIK3CA, RET, ROS1, NTRK1, NTRK2, NTRK3
Mechanism of Action
GDC-0077- PI3K inhibitor; Alectinib - ALK kinase inhibitor; Entrectinib - inhibitor of the tyrosine kinases TrkA, TrkB, TrkC, ROS1 and ALK; Atezolizumab - PD-L1 antibody; Pralsetinib - RET inhibitor; Belvarafenib - BRAF inhibitor
Purpose
In this study, the sponsor and investigators want to learn:
- The effects, good or bad, of targeted therapies or immunotherapy (drugs that help the body's immune system fight cancer cells) on participants who have solid tumors with specific genetic alterations or with a high number of mutations.
Inclusion Criteria
- 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: 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
- Eligibility based on pre-existing standard of care NGS test result from a sponsor approved lab.
- In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
| Cohort | Biomarker |
| Cohort A | ROS1 fusion-positive tumors |
| Cohort B | NTRK1/2/3 fusion-positive tumors |
| Cohort C | ALK fusion-positive tumors |
| Cohort D | TMB-high tumors |
| Cohort E | AKT1/2/3 mutant-positive tumors |
| Cohort F | HER2 mutant-positive tumors |
| Cohort H | PIK3CA multiple mutant-positive tumors |
| Cohort I | BRAF class II mutant/fusion-positive tumors |
| Cohort J | BRAF class III mutant-positive tumors |
| Cohort K | RET fusion-positive tumors |
Exclusion Criteria
- Current participation or enrollment in another therapeutic clinical trial
- Any anticancer treatment within 2 weeks or 5 half-lives (whichever is longer) 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
| Cohort | Biomarker |
| Cohort A | ROS1 fusion-positive tumors |
| Cohort B | NTRK1/2/3 fusion-positive tumors |
| Cohort C | ALK fusion-positive tumors |
| Cohort D | TMB-high tumors |
| Cohort E | AKT1/2/3 mutant-positive tumors |
| Cohort F | HER2 mutant-positive tumors |
| Cohort H | PIK3CA multiple mutant-positive tumors |
| Cohort I | BRAF class II mutant/fusion-positive tumors |
| Cohort J | BRAF class III mutant-positive tumors |
| Cohort K | RET fusion-positive tumors |
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
