Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors
Lead Sponsor:
Intra-IMMUSG Pte Ltd
Collaborating Sponsors:
Parexel
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04452955
Start Date
December 12 2020
End Date
March 1 2026
Last Update
December 2 2025
Active Locations (5)
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1
HonorHealth Research
Scottsdale, Arizona, United States, 85258
2
St. Jude Medical Center
Fullerton, California, United States, 92835
3
The Angeles Clinic
Los Angeles, California, United States, 90025
4
Norton Healthcare
Louisville, Kentucky, United States, 40200