A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors

Key Inclusion Criteria:

• Pathologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
• Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.
• Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s).
• Adequate organ function based on laboratory values.
• If there is a known history of brain metastases, either treated or untreated, the disease must be stable.
• Willing and able to provide written Informed Consent and comply with the requirements of the study.

Key Exclusion Criteria:

• Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.
• Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
• Presence of an acute or chronic toxicity of prior chemotherapy, that has not resolved to ≤Grade 1, as determined by CTCAE v 4.0.
• Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic disease.
• Bone marrow reserve which is not adequate for participation in this trial.
• Radiotherapy within 28 days prior to baseline.
• Fraction of radiotherapy to >25 % of bone marrow.
• Major surgery within 28 days prior to initiation of study drug.
• Active bacterial, viral, or fungal infection requiring systemic therapy.
• Known human immunodeficiency virus or acquired immunodeficiency syndrome related illness.
• Clinically significant hearing impairment, as judged by the Principal Investigator.
• Uncontrolled cardiovascular abnormalities.
• Previous malignancy, except for non-squamous-cell carcinoma of skin or carcinoma in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.