- Patients with a locally advanced or metastatic solid tumor who: (1) have progressed on or are intolerant to standard therapy, or (2) no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or (3) decline standard therapy
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Prior MKIs with anti-RET activity are allowed. However, prior treatment with a selective RET inhibitor(s) is prohibited
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Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
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ECOG score of 0, 1, or 2 or Lansky Performance Score (LPS) >/= 40% (age < 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment.
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Adequate hematologic, hepatic and renal function.
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Life expectancy of at least 3 months.
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Phase 2 - Cohorts 1 and 3: Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
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Phase 2 - Cohorts 1-4: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor. However, a positive germline DNA test for a RET gene mutation is acceptable in the absence of tumor tissue testing for patients with MTC.
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Phase 2 - Cohorts 1-4: at least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated.
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Phase 2 - Cohort 4: radiographic PD within the previous 14 months.
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Please contact study team for more inclusion criteria.
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