A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic
solid tumor (including non-Hodgkin Lymphoma) (Stage IV, AJCC v.7) that harbors an ALK,
ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.

2. ECOG PS 0-1.

3. Age ≥18 (or age ≥ 20 of age as required by local regulation).

4. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only
measurable disease as defined by RECIST version 1.1 is allowed.

5. Prior cytotoxic chemotherapy is allowed.

6. Prior immunotherapy is allowed.

7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer
therapy to National Cancer Institute Common Terminology Criteria for Adverse Events
(NCI CTCAE) Version 4.03 Grade less than or equal to 1.

8. Patients with asymptomatic CNS involvement are allowed.

9. Life expectancy ≥ 3 months.

Key Exclusion Criteria:

1. Concurrent participation in another therapeutic clinical trial.

2. Symptomatic CNS involvement.

3. Any of the following cardiovascular history in the past 6 months: myocardial
infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic
congestive heart failure, cerebrovascular accident or transient ischemic attack,
pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for
anti-arrhythmic medication.

4. History of prolonged QTc interval.

5. Known active infections (bacterial, fungal, viral including HIV positivity).

6. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut
syndrome) or other malabsorption syndromes that would impact drug absorption.

7. Peripheral neuropathy ≥ Grade 2.

8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase
inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis
are not excluded.