क्लिनिकल ट्रायल रडार

Disease status:

• Phase 1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1

• Phase 2 portion:

  • Part B: Participants must have measurable or evaluable disease, as defined by RANO
  • Part C (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale
  • Part D: Participants must have measurable or evaluable disease, as defined by RECIST v1.1
  • Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO

Tumor type:

• Phase 1 portion:

  * Part A: Relapsed or refractory extracranial solid tumors

• Phase 2 portion

  • Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method
  • Part D: Extracranial solid tumors (including NB) with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method

Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse

Archival tumor tissue from diagnosis or, preferably, at relapse

Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks

Prior therapy: Participants must have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options for solid tumors and primary CNS tumors that are neurotrophic tyrosine receptor kinase (NTRK) or ROS1 fusion-positive

Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment

Adequate organ and neurologic function

Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Agreement to remain abstinent or use use combined contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment.

For male participants with a female partner of childbearing potential or a pregnant female partner: Agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of study drug