NCT04452955Active, not recruitingPhase 2
An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors
Intra-IMMUSG Pte Ltd10 sites in 1 country51 target enrollmentStarted: December 12, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Intra-IMMUSG Pte Ltd
- Enrollment
- 51
- Locations
- 10
- Primary Endpoint
- Progression free survival (PFS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
PRL3-zumab
Experimental
All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.
Intervention: PRL3-zumab (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Objective Response Rate (ORR)(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first.)
- Clinical benefit rate (CBR)(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first)
- Overall survival (OS)(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first)
- Duration of response(Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first)
- Terminal elimination half life (t½)(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.)
- Maximum plasma PRL3-zumab concentration (Cmax)(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)(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)(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(From first dose of study drug until disease progression or end of treatment, whichever comes first)
- European Quality-5D (EQ-5D)(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)(From first dose of study drug until disease progression or end of treatment, whichever comes first)
Investigators
Study Sites (10)
Loading locations...
Similar Trials
Completed
Phase 2
Phase II Study of PRL3-ZUMAB in Advanced Solid TumorsGastric CancerAdvanced Solid TumorHepatocellular CarcinomaNCT04118114National Cancer Centre, Singapore14
Completed
Phase 3
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B PatientsHemophilia BNCT03569891CSL Behring67
Completed
Phase 3
Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin AnaloguesAcromegalyNCT02354508Novartis Pharmaceuticals123
Completed
Phase 3
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian CancerOvarian CancerNCT03180307On Target Laboratories, LLC140
Completed
Phase 3
A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)Biliary Tract CancersNCT05924880AstraZeneca116