Clinical trial NCT04452955: A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients with Solid Tumors
Official title: An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Solid Tumor
Keywords: PRL-3
Tumor
Efficacy
Safety
Pharmacokinetics
Lead sponsor: Intra-IMMUSG Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2020-07-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: From first dose of study drug until disease progression or end of treatment, whichever comes first
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first.
measure: Clinical benefit rate (CBR)
timeFrame: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
measure: Overall survival (OS)
timeFrame: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
measure: Duration of response
timeFrame: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
measure: Terminal elimination half life (t½)
timeFrame: 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.
measure: Maximum plasma PRL3-zumab concentration (Cmax)
timeFrame: 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.
measure: Time of Cmax (tmax)
timeFrame: 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.
measure: Area under the concentration time curve from pre-dose (AUCinf)
timeFrame: 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.
measure: Number of patients with adverse events and serious adverse events
timeFrame: From first dose of study drug until disease progression or end of treatment, whichever comes first
measure: European Quality-5D (EQ-5D)
timeFrame: From first dose of study drug until disease progression or end of treatment, whichever comes first
measure: European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)
timeFrame: From first dose of study drug until disease progression or end of treatment, whichever comes first
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research
state: Arizona
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic
state: California
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
Study officials:
References: