Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients
brief summary
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.
detailed description
Safety:
Patient safety will be evaluated based on physical examination, vital signs (blood pressure \[systolic and diastolic\], heart rate, respiratory rate, and temperature), clinical laboratory tests (hematology, clinical chemistry, coagulation) and adverse events per CTCAE v5. Patient safety will be assessed on an ongoing basis during each cycle.
Quality of life assessment EQ-5D and EORTC-QLQ-C30 questionnaire scores will be obtained at Screening and every 2 cycles (8 weeks ± 2 days) for C1 to C4 and 8 weeks ±7 days for the rest of the scheduled visits) for the duration of the study.
DURATION OF THE STUDY:
The planned duration of the treatment is till patient meets discontinuation criteria. In addition, the study includes a patient enrolment period of 14 days, EOT visit within 14 days after last dose of study treatment and an EOS visit for safety follow-up 28 days after the last dose of study treatment. Survival study follow-up call will be done monthly till 6 months after EOS visit.
Cycle Period Per Treatment:
One cycle of treatment will be 2 infusions administration (4-week) (PK T1/2= 12 days ±2 days for each infusion).
Treatment Period:
PRL3-zumab will be administered till progression of disease (iRECIST or clinical criteria), intolerable toxicity or withdrawal of consent.
STATISTICAL CONSIDERATIONS:
Sample Size Determination Sample size: for alpha, α = 0.05 and power, β = 0.9 PRL3-zumab therapy: 30% PRL3-zumab therapy min response rate: 10% Number of patients in each arms (treatment group) for phase II (Stage): 22 Response R: 2 No patients in each arms (treatment group): 33 Response R: 6 Total patients adjusted for 10% dropout:42 Total patients adjusted for 20% dropout: 52
Sample size was estimated based on the primary efficacy parameter, which is the PFS or TTP as per iRECIST criteria base on the investigator's assessment of tumor response for patients with PRL3-zumab. The tumor response of the Solid Tumor is defined as Progression Free Survival (PFS) or Time to progression (TTP) with minimum survival of 6 months.
official title
An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients