A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors

Solid Tumor Clinical Trial

Official title:

An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452955
• Other study ID #: 226688
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Intra-IMMUSG Pte Ltd
• Contact: Rio Aquino
• Phone: +1 562 359-9666
• Email: Rio.Aquino[@]PAREXEL.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• PRL3-zumab
Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)

Locations

Country	Name	City	State
United States	St. Jude Medical Center	Fullerton	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	The Angeles Clinic	Los Angeles	California
United States	Norton Healthcare	Louisville	Kentucky
United States	HonorHealth Research	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Intra-IMMUSG Pte Ltd	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Primary	Objective response rate (ORR)	ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 and iRECIST criteria from time of initiation of study treatment.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Primary	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.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Primary	Overall survival (OS)	OS is defined as the time from the initiation of study treatment to death from any cause.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Primary	Duration of response	Duration of response is defined as the time from the initial documented response (CR or PR) to the first documented sign of disease progression as per RECIST v1.1 and iRECIST criteria or death.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Secondary	Maximum plasma PRL3-zumab concentration (Cmax)	To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab.	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.
Secondary	Time of Cmax (tmax)	To assess PK after single and multiple dose administration of PRL3-zumab.	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.
Secondary	Area under the concentration time curve from pre-dose (AUCinf)	To assess PK after single and multiple dose administration of PRL3-zumab.	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.
Secondary	Terminal elimination half life (t½)	To assess PK after single and multiple dose administration of PRL3-zumab.	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.
Secondary	Number of patients with adverse events and serious adverse events	To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Secondary	European Quality-5D (EQ-5D)	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").	From first dose of study drug until disease progression or end of treatment, whichever comes first
Secondary	European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)	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.	From first dose of study drug until disease progression or end of treatment, whichever comes first
Secondary	Eastern Cooperative Oncology Group Performance Status (ECOG PS)	To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.	From first dose of study drug until disease progression or end of treatment, whichever comes first