Study on RET Inhibitor TAS0953/HM06 for Patients with Advanced Solid Tumors with RET Gene Abnormalities

Inclusion Criteria

• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have RET gene abnormalities confirmed by a tissue or blood test.
• Must have cancer that has progressed after previous treatments or cannot receive such treatments.
• Must have adequate blood, liver, and kidney function.

Phase I Dose-Escalation:

• Must have advanced solid tumors.
• Must have measurable or non-measurable disease.
• If there are brain or spinal fluid metastases, they must be asymptomatic.

Phase I Dose-Expansion:

• Must have advanced non-small cell lung cancer (NSCLC) with RET gene fusion and previous treatment with RET inhibitors.
• Must have measurable disease.
• If there are brain or spinal fluid metastases, they must be asymptomatic and either untreated or treated and stable.

Phase II:

• Must have RET gene abnormalities confirmed by a tissue or blood test.
• Must have advanced NSCLC with or without previous RET inhibitor treatment, or other advanced solid tumors with RET abnormalities.
• Must have a performance status score of 0 to 2.
• Must have measurable disease.
• If there are brain or spinal fluid metastases, they must be asymptomatic and either untreated or treated and stable.
• Must have adequate blood, liver, and kidney function.

Exclusion Criteria

• Cannot have taken investigational drugs or cancer therapy within a certain time before starting the study drug.
• Cannot have had major surgery recently or plan to have major surgery during the study.
• Cannot have had whole brain radiation recently or have ongoing side effects from such treatment.
• Cannot have significant, uncontrolled heart disease or high blood pressure.
• Cannot have a prolonged QT interval on an ECG or a history of certain heart rhythm problems.
• Cannot be taking certain medications that affect the liver enzyme CYP3A4.

Phase I Dose-Expansion and Phase II:

• Cannot have known mutations in other specific cancer-related genes like EGFR, KRAS, ALK, HER2, ROS1, BRAF, and METex14.