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

Overview

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 and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC). Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2021

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 is no longer enrolling. The Dose Expansion Phase is commencing in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).

Interventions

  • Drug: PT-112 Injection

Arms, Groups and Cohorts

  • Experimental: PT-112 injection
    • PT-112 Injection, administered by intravenous infusion

Clinical Trial Outcome Measures

Primary Measures

  • Determine the safety and tolerability, Dose Limiting Toxicity(ies) (DLT), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose(s) (RP2D)
    • Time Frame: 28-day cycle
    • The primary endpoint is to determine the safety profile and MTD of PT-112 Injection. Assessments will include drug exposure; characterization of DLTs; characterization of the type, incidence, severity, seriousness, and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.
  • Assess the pharmacokinetic (PK) profile
    • Time Frame: First 28-day cycle
    • PK (pharmacokinetic) parameters, including but not limited to area under the curve (AUC), maximum plasma concentration (Cmax), trough plasma concentration (Cmin), time to maximum plasma concentration (Tmax), and plasma half-life (T1/2) will be determined.

Secondary Measures

  • Document any observed anti-tumor effects
    • Time Frame: Day 1, Day 56 and every 56 days subsequently
    • Subjects will be assessed for clinical activity of PT-112 Injection every 2 cycles by appropriate physical examination or computed tomography imaging techniques, using RECIST v1.1; and, where appropriate, informative tumor markers every cycle.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Phosplatin Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel D. Karp, MD, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • Jason Summa, (617) 335-1794, jsumma@phosplatin.com

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