Clinical Trial Finder

Inclusion Criteria:

• - Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies.

• - Evidence of an activating RET gene alteration in the tumor and/or blood.

• - Measurable or non-measurable disease.

• - Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50.

• - Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days.

• - Adequate hematologic, hepatic and renal function.

• - Ability to receive study drug therapy orally or via gastric access.

• - Willingness of men and women of reproductive potential to observe conventional and effective birth control.

Exclusion Criteria:

• - Major surgery within two weeks prior to planned start of LOXO-292.

• - Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292.

• - Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.

• - Clinically significant active malabsorption syndrome.

• - Pregnancy or lactation.

• - Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292) - Uncontrolled symptomatic hypercalcemia or hypocalcemia.

• - Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension.

- Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s])

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.

Arms

Experimental: LOXO-292

Phase 1- Dose Escalation and determination of MTD; multiple dose levels of LOXO-292 to be evaluated; Phase 2 - The MTD/recommended dose from Phase 1

Interventions

Drug: - LOXO-292

Oral LOXO-292