This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

Brief Title

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

Official Title

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

Brief Summary

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be <br /> conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose <br /> Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 <br /> dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK <br /> (pharmacokinetics). <br /> <br /> The Dose Escalation Phase is no longer enrolling. <br /> <br /> The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with <br /> thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic <br /> castrate-resistant prostate cancer (mCRPC) (Cohort D).

Detailed Description

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be
conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase

The Dose Escalation Phase and the Dose Expansion Thymoma Cohort are no longer enrolling.

The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate
cancer (mCRPC) is open and enrolling.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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.