Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients
ConditionAdvanced Solid Cancers
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIntra-IMMUSG Pte Ltd
About this trial
This is a Multi-Center, Phase II/III, open-label, single dose level (6 mg/kg) basket trial of PRL3-zumab monotherapy in solid cancer patients.
The study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1/2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up/EOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit.
PRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 18 - 75 years with solid tumors
Willing to provide written informed consent for the study.
Histopathological diagnosis and metastatic status cancer at study entry.
Stage 1-3 patients with no more than 3 prior lines of treatment
Disqualifiers
Patient has known untreated or symptomatic central nervous system metastasis.
Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.
Patient has known history of human immunodeficiency virus (HIV) infection (HIV-1 or HIV-2 antibodies).
Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.
Trial design
Design model
Single group
Treatments tested in this trial
PRL3-ZUMAB
Biological/VaccinePRL3-zumab will be administered every 2-week/dose till patient progress or develops intolerable toxicity or withdraw consent. A dose at 10-days is allowed at the first 4 doses when patients had heavier tumor burden since PRL3-zumab PK t ½ = 12 days (±2 days).
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Experimental: PRL3-ZUMAB MonotherapyOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.2
Time to Progression (TTP)
TTP is defined as the time from the the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria which does not include deaths.
Time frame
From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.Secondary outcomes
1
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.
Time frame
Time Frame: From date of first dose of study drug until first documented disease progression or date of death, whichever comes first, assessed at every 8 weeks up to 48 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Intra-IMMUSG Pte Ltd
Lead sponsor
Kuala Lumpur General Hospital
Collaborator
Beacon Hospital
Collaborator
Hospital Universiti Sains Malaysia
Collaborator
University Malaysia Medical Centre
Collaborator
Source ClinicalTrials.gov