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
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
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Djuro, Victor; Walton, Sherri
Trial Phone: 321.841.9821 ; 321.841.7477 ; 321.841.1907
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IRB No: W23.014.01
Protocol Abbrev: PT-112-101
Principal Investigator: Daniel Ari Landau, MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: PT-112-101
Treatment: Experimental: Arm 1: PT-112 injection Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2 (no longer enrolling) Drug: PT-112 Injection Other Name: PT-112 Experimental: Arm 2: PT-112 injection Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2 Drug: PT-112 Injection Other Name: PT-112 Experimental: Arm 3: PT-112 injection Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses Drug: PT-112 Injection Other Name: PT-112
ClinicalTrials.gov ID: NCT02266745
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Objective
The Dose Escalation represents the Phase 1 escalation of the study protocol in many advanced solid tumors.
The primary objective was to determine the safety and tolerability, DLTs, MTD, and recommended Phase 2 dose(s) (RP2D) of IV administered PT-112 Injection in patients with advanced solid tumors.
Expansion Cohort A represents a Phase 2 expansion of the study protocol in a well-defined disease population of late-line metastatic thymoma and thymic cancer patients.
The primary objective of this cohort is to determine the objective response rate, defined as the percentage of patients with ITMIG modified RECIST complete responses (CR) of partial responses (PR), based on tumor assessments at baseline and after every 2 cycles (8 ±1 weeks) of treatment -
Key Eligibility
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.