A Study 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 six (12) patients will be enrolled in Arm
3.

Once the dosing schedule has been established in Arm 2, up to 40 additional patients may be
enrolled in Arm 4 for confirmation of safety.

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

- Patients with histologically confirmed locally advanced or metastatic colon, gastric,
ovarian, bladder cancers, as well as cholangiocarcinomas or hepatomas in Arm 4

- 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, 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