A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors

An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: PRL3-zumab

Detailed Description

The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rio Aquino; Phone Number: +1 562 359-9666; Email: Rio.Aquino@PAREXEL.com
• Study Contact Backup: Name: Qi Zeng; Email: mcbzengq@imcb.a-star.edu.sg

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • HonorHealth Research
      • Contact: Irfan Uddin
  • California
    • Fullerton, California, United States, 92835
      • Recruiting
      • St. Jude Medical Center
      • Contact: Blanca Sanchez
    • Los Angeles, California, United States, 90025
      • Recruiting
      • The Angeles Clinic
      • Contact: Roland Menendez
  • Kentucky
    • Louisville, Kentucky, United States, 40200
      • Recruiting
      • Norton Healthcare
      • Contact: Kylee Fleig
  • Nevada
    • Las Vegas, Nevada, United States, 89014
      • Recruiting
      • Comprehensive Cancer Centers of Nevada
      • Contact: Karishma Gupta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with unresectable or metastatic solid tumors willing to provide signed informed consent.
• Histopathological diagnosis and metastatic status cancer at study entry.
• Must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease.
• Life expectancy of more than 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than 2.
• Adequate organ and hematological function.
• Measurable disease by RECIST v1.1 and iRECIST.

Exclusion Criteria:

• Patient has known untreated or symptomatic central nervous system metastasis.
• Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition.
• Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.
• Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.
• Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment.
• Patient has received > 3 lines of prior systemic chemotherapy for metastatic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRL3-zumab; All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.	Biological: PRL3-zumab; Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Objective response rate (ORR)	ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 and iRECIST criteria from time of initiation of study treatment.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Clinical benefit rate (CBR)	CBR is defined as the percentage of patients with CR, PR, or stable disease (SD) as per RECIST v1.1 and iRECIST criteria based on Investigator's assessment.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Overall survival (OS)	OS is defined as the time from the initiation of study treatment to death from any cause.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Duration of response	Duration of response is defined as the time from the initial documented response (CR or PR) to the first documented sign of disease progression as per RECIST v1.1 and iRECIST criteria or death.	From first dose of study drug until disease progression or end of treatment, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma PRL3-zumab concentration (Cmax)	To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab.	Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
Time of Cmax (tmax)	To assess PK after single and multiple dose administration of PRL3-zumab.	Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
Area under the concentration time curve from pre-dose (AUCinf)	To assess PK after single and multiple dose administration of PRL3-zumab.	Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
Terminal elimination half life (t½)	To assess PK after single and multiple dose administration of PRL3-zumab.	Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
Number of patients with adverse events and serious adverse events	To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.	From first dose of study drug until disease progression or end of treatment, whichever comes first
European Quality-5D (EQ-5D)	The system comprises 5 questions, 1 for each of 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each is rated according to 3 response levels ("no problems," "some problems," or "extreme problems").	From first dose of study drug until disease progression or end of treatment, whichever comes first
European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)	Health-related quality of life is measured by EORTC-QLQ-C30, a 30 item questionnaire. This scale consists of functioning scales and symptom scales. For functioning scales higher scores suggest better functioning; for symptom scales higher scores suggest higher symptom burden.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Eastern Cooperative Oncology Group Performance Status (ECOG PS)	To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.	From first dose of study drug until disease progression or end of treatment, whichever comes first

Collaborators and Investigators

• Sponsor: Intra-IMMUSG Pte Ltd
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Pharmacokinetics; Tumor; PRL-3
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 226688

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No