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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452955
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : March 1, 2023
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Intra-IMMUSG Pte Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: PRL3-zumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors
Actual Study Start Date : December 12, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 1, 2023
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    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.

  2. Objective response rate (ORR) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    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.

  3. Clinical benefit rate (CBR) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    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.

  4. Overall survival (OS) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    OS is defined as the time from the initiation of study treatment to death from any cause.

  5. Duration of response [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    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.


Secondary Outcome Measures :
  1. Maximum plasma PRL3-zumab concentration (Cmax) [ Time Frame: 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. ]
    To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab.

  2. Time of Cmax (tmax) [ Time Frame: 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. ]
    To assess PK after single and multiple dose administration of PRL3-zumab.

  3. Area under the concentration time curve from pre-dose (AUCinf) [ Time Frame: 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. ]
    To assess PK after single and multiple dose administration of PRL3-zumab.

  4. Terminal elimination half life (t½) [ Time Frame: 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. ]
    To assess PK after single and multiple dose administration of PRL3-zumab.

  5. Number of patients with adverse events and serious adverse events [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.

  6. European Quality-5D (EQ-5D) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    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").

  7. European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    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.

  8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first ]
    To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452955


Contacts
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Contact: Rio Aquino +1 562 359-9666 Rio.Aquino@PAREXEL.com
Contact: Qi Zeng mcbzengq@imcb.a-star.edu.sg

Locations
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United States, Arizona
HonorHealth Research Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Irfan Uddin         
United States, California
St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Blanca Sanchez         
The Angeles Clinic Recruiting
Los Angeles, California, United States, 90025
Contact: Roland Menendez         
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40200
Contact: Kylee Fleig         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89014
Contact: Karishma Gupta         
Sponsors and Collaborators
Intra-IMMUSG Pte Ltd
Parexel
More Information
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Responsible Party: Intra-IMMUSG Pte Ltd
ClinicalTrials.gov Identifier: NCT04452955    
Other Study ID Numbers: 226688
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intra-IMMUSG Pte Ltd:
PRL-3
Tumor
Efficacy
Safety
Pharmacokinetics
Additional relevant MeSH terms:
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Neoplasms