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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 : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Intra-IMMUSG Pte Ltd

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 - 21 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 30 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, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 2-weeks ±2 days apart).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 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
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : September 4, 2021
Estimated Study Completion Date : January 14, 2022

Arm Intervention/treatment
Experimental: PRL3-zumab
All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 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)




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first (up to approximately 6 months) ]
    ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 criteria from time of initiation of study treatment.

  2. Progression free survival (PFS) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first (up to approximately 6 months) ]
    PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 criteria.

  3. Overall survival (OS) [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first (up to approximately 6 months) ]
    OS is defined as the time from the initiation of study treatment to death from any cause.

  4. Duration of response [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first (up to approximately 6 months) ]
    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 criteria or death.

  5. Clinical benefit rate (CBR) [ Time Frame: Up to approximately 6 months ]
    CBR is defined as the percentage of patients with CR, PR, or stable disease (SD) as per RECIST v1.1 criteria based on Investigator's assessment.

  6. Time to response [ Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first (up to approximately 6 months) ]
    Time to response is defined as the time between the initiation of study treatment and the first documented CR or PR as per RECIST v1.1 criteria.


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: Up to approximately 6 months ]
    To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.

  6. Incidence of anti drug antibody (ADA) [ Time Frame: Up to approximately 6 months ]
    To characterize immunogenicity of PRL3-zumab.

  7. European Quality‑5D (EQ-5D) [ Time Frame: Up to approximately 6 months ]
    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").

  8. European Organization for Research and Treatment of Cancer‑quality of life quantionnaire‑C30 (EORTC-QLQ-C30) [ Time Frame: Up to approximately 6 months ]
    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.

  9. Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Up to approximately 6 months ]
    To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • 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.

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

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: Deb Hamilton +1 978 313-1697 Deb.Hamilton@parexel.com
Contact: Qi Zeng mcbzengq@imcb.a-star.edu.sg

Sponsors and Collaborators
Intra-IMMUSG Pte Ltd
Parexel
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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: July 31, 2020
Last Verified: June 2020

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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