The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations.
The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks.
The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles.
The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).
Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment, but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.
Patient must have ECOG performance status of 0 or 1.
Subjects must be 18-year-old or older.
Subjects must have measurable disease according to RECIST 1.1.
Subjects with leptomeningeal disease should be excluded from this clinical trial.
Subjects with known unstable brain metastases should be excluded from this clinical trial. Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.
Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
Subjects with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF < 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Single group
Atezolizumab
Drug1200 mg, administered IV, once every 3 weeks
Futibatinib
Drug20 mg administered orally, once daily (QD) continuously in 28-day cycles.
Amivantamab
Drug1050 mg administered IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles)
Overall response rate
Proportion of patients with a partial response \[PR\] or complete response \[CR\] per RECIST v1.1.
Progression free survival (PFS by RECIST 1.1)
Time from the first dose date of study treatment to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.
Overall Survival
Time from beginning treatment to the time of death from any cause.
Duration of response
Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.
Health-related quality of life (HRQoL)
Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)
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Vall d'Hebron Institute of Oncology
Lead sponsor
Roche Pharma AG
Collaborator
IQVIA Pty Ltd
Collaborator
Taisho Pharmaceutical Co., Ltd.
Collaborator
Janssen, LP
Collaborator
