Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients
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 Per
| Condition(s) | Advanced Solid Cancers |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Men and women aged 18 - 75 years with solid tumors 2. Willing to provide written informed consent for the study. 3. Histopathological diagnosis and metastatic status cancer at study entry. 4. Stage 1-3 patients with no more than 3 prior lines of treatment 5. Life expectancy of more than 6 months (especially for Pancreatic cancer patients). 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 7. Patient should have recovered from toxicity of prior treatment regimen to Grade 1 level except for alopecia or peripheral neuropathy or fatigue as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5. 8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at study entry and must follow highly |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Intra-IMMUSG Pte Ltd |
| Locations | Kota Bharu, Malaysia; Kuala Lumpur, Malaysia; Kuala Lumpur, Malaysia; Kuala Lumpur, Malaysia |
| Start date | 2023-01-09 |
| NCT ID | NCT07290088 |
| Official listing | https://clinicaltrials.gov/study/NCT07290088 |