Clinical trial · Interventional
A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors
An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors
NCT04452955CI-TRIAL-00109074active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRL3-zumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRL3-zumab
- description
- All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.
- interventionNames
- Biological: PRL3-zumab
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- From first dose of study drug until disease progression or end of treatment, whichever comes first
- description
- 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.
Secondary outcomes (11)
- measure
- Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPark DJ, Thura M, Chiu VK, Vicuna B, Ang KH, Sanchez B, Chia PL, Kuan KY, Li J, Zhang K, Zheng WH, Hsien Ng MC, Zeng Q. The PRL3-zumab paradigm: A multicenter, single-dose-level phase 2 basket clinical trial design of an unconventional cancer immunotherapy. Cell Rep Med. 2025 May 20;6(5):102120. doi: 10.1016/j.xcrm.2025.102120. Epub 2025 May 8. PMID 40345181