Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
NCT #
NCT04589845
Condition(s)
Solid Tumors
Molecular Target(s)
[AKT1/2/3 mutant] tumors, [ALK fusion] tumors, [HER2 mutant] tumors, [MDM2-amplified, [NTRK 1/2/3 fusion] tumors, [PIK3CA multiple mutant] tumors, [ROS1 fusion] tumors, TMB-high Solid Tumors, TP53 wild-type] tumors
Drug Classification(s)
Antibody Drug Conjugate, Monoclonal Antibody, Small Molecule, Targeted Therapy
Agents(s)
Receipt of XL102 or any other selective CDK7 inhibitor
Phase(s)
II
Mechanism of Action
- GDC-0077- PI3K inhibitor
- Idasanutlin – MDM2 protein antagonist
- Alectinib – ALK kinase inhibitor
- trastuzumab Emtansine – HER2 antibody-drug conjugate
- Ipatasertib – AKT inhibitor
- Atezolizumab – PD-L1 immunotherapy
- Entrectinib – inhibitor of the tyrosine kinases TrkA, TrkB, TrkC, ROS1 and ALK
Purpose
The purpose of this study is to compare 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. Participants will be assigned to cohorts (groups) based on having a specific type of genetic alteration or having a high number of mutations in their tumor.
- 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)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- 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
- 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
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
Location
MCD
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