Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
226688
- NCT ID:
NCT04452955
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| PRL3-zumab | | PRL3-zumab |
Purpose
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 - 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).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| PRL3-zumab | Experimental | All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 criteria, or unacceptable toxicity, or withdraws consent. | |
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.
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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) |
| Safety Issue: | |
| Description: | 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. |
Secondary Outcome Measures
| Measure: | 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. |
| Safety Issue: | |
| Description: | To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab. |
| Measure: | 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. |
| Safety Issue: | |
| Description: | To assess PK after single and multiple dose administration of PRL3-zumab. |
| Measure: | 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. |
| Safety Issue: | |
| Description: | To assess PK after single and multiple dose administration of PRL3-zumab. |
| Measure: | 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. |
| Safety Issue: | |
| Description: | To assess PK after single and multiple dose administration of PRL3-zumab. |
| Measure: | Number of patients with adverse events and serious adverse events |
| Time Frame: | Up to approximately 6 months |
| Safety Issue: | |
| Description: | To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors. |
| Measure: | Incidence of anti drug antibody (ADA) |
| Time Frame: | Up to approximately 6 months |
| Safety Issue: | |
| Description: | To characterize immunogenicity of PRL3-zumab. |
| Measure: | European Quality-5D (EQ-5D) |
| Time Frame: | Up to approximately 6 months |
| Safety Issue: | |
| Description: | 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"). |
| Measure: | European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30) |
| Time Frame: | Up to approximately 6 months |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Eastern Cooperative Oncology Group Performance Status (ECOG PS) |
| Time Frame: | Up to approximately 6 months |
| Safety Issue: | |
| Description: | To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Intra-IMMUSG Pte Ltd |
Trial Keywords
- PRL-3
- Tumor
- Efficacy
- Safety
- Pharmacokinetics
Last Updated
June 15, 2021
