A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors

This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.

Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.

In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.

Inclusion criteria

• Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
• Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
• Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
• Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
• Measurable disease per RECIST 1.1 (primary or metastases)

Exclusion criteria

• New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Pregnant or nursing women
• Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
• Unwillingness or inability to comply with procedures required in this protocol
• Known active infection with HIV, hepatitis B, hepatitis C
• Symptomatic brain metastases
• Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• Patients who are currently receiving any other investigational agent