An Open-Label Phase I/II Clinical Study of PT-112 in Combination With Docetaxel in Subjects With Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects With Non-Small Cell Lung Cancer (NSCLC) in a Phase II Dose Confirmation Study

1. Male or female ≥ 20 years of age on the day of signing informed consent.

2. Subjects with advanced tumor of any histological type and meet the following eligibility criteria for the corresponding part of the study:

* In Part 1, the subjects who failed at least one prior therapy must have pathologically confirmed advanced solid tumor of any histological type with preference of subjects with advanced NSCLC and either no available, or intolerable to, standard of-care treatment.

* In Part 2, the subjects must have pathologically confirmed advanced NSCLC. Subjects are required to have evidence of measurable disease per RECIST v1.1.

3. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.

4. Subject must have adequate organ function as indicated by the following laboratory values:

* Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.

* Platelets ≥ 100 × 109/L.

* Hemoglobin ≥ 90 g/L or 5.6 mmol/L.

* Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or calculated or directly measured creatinine clearance ≥ 60% lower limit of normal (LLN).

* Serum total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits).

* Aspartate aminotransferase (AST \[SGOT\]) and/or alanine aminotransferase (ALT \[SGPT\]) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases.

* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.

* Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.

* Albumin ≥ 3 mg/dL.

5. Female subjects are eligible to enter and participate in the study if they are of:

* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who

* has had a hysterectomy

* has had a bilateral oophorectomy (ovariectomy)

* has had a bilateral tubal ligation

* is post-menopausal (total cessation of menses for ≥ 1 year)

* Childbearing potential, have a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), are not breast feeding, and use adequate contraception before study entry and throughout the study until 180 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:

* Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.

* Any intra-uterine device with a documented failure rate of less than 1% per year.

* Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; or diaphragm with spermicide; or male condom and diaphragm.

6. Male subjects are eligible to enter and participate in the study if they are vasectomized or agree to use of contraception during the study treatment period and for at least 180 days after the last dose of the study drug.

7. Willing and able to provide written informed consent and comply with the requirements of the study.

What this study is about