PRL3-zumab treatment for advanced solid cancers

An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients

This Phase II/III study will test whether IV PRL3-zumab (6 mg/kg) given every two weeks can control tumors and is safe in adults with advanced solid cancers.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Intra-IMMUSG Pte Ltd (Industry-sponsored)
• Drugs / interventions: radiation, zumab, immunotherapy
• Locations: 4 sites (Kota Bharu and 3 other locations)
• Trial ID: NCT07290088 on ClinicalTrials.gov

What this trial studies

This is a multi-center, open-label Phase II/III basket trial giving a single dose level of PRL3-zumab (6 mg/kg) by intravenous infusion, with two infusions per 4-week cycle and dosing continued until disease progression, intolerable toxicity, or withdrawal of consent. Safety will be closely monitored with physical exams, vital signs, labs, and adverse event reporting per CTCAE v5, and quality of life will be tracked using EQ-5D and EORTC-QLQ-C30 questionnaires at scheduled intervals. The protocol includes screening, regular 2-week clinic visits for PK and safety, an end-of-treatment visit, a 28-day safety follow-up, and monthly survival calls for up to 6 months after follow-up. Sample size planning targets statistical power to detect a predefined response rate compared with a low baseline rate.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed solid tumors, ECOG performance status 0–1, adequate organ function, and who meet the protocol's prior-treatment and contraceptive requirements are the intended participants.

Not a fit: Patients with poor performance status, inadequate organ function, active uncontrolled comorbidities, or those who have already experienced rapid progression despite multiple prior therapies are less likely to benefit.

Why it matters

Potential benefit: If effective, PRL3-zumab could offer a new systemic treatment option that slows disease progression for some patients with advanced solid tumors.

How similar studies have performed: Targeting PRL-3 with an antibody is a relatively novel approach with limited early-phase clinical data but has not yet shown definitive success in large trials.

Eligibility criteria

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 effective contraception
9. Adequate organ and hematological function as evidenced by the following laboratory studies within 10 days of treatment:

   * Absolute neutrophil count ≥ 1.0 x 109/L.
   * Platelet count ≥ 75 x 109/L. Hemoglobin ≥ 90 g/L (9 g/dL).
   * Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
   * Total bilirubin ≤ 1.5x ULN.
   * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in the presence of liver metastases).
   * For patients with hepatocellular carcinoma (HCC) Child Pugh score of ≤ B7.
   * Creatinine \< 1.5x ULN.
10. Measurable disease by iRECIST.
11. No history of active hepatitis B or C infection.

Exclusion Criteria:

1. Patient has known untreated or symptomatic central nervous system metastasis.
2. Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.
3. Patient has known history of human immunodeficiency virus (HIV) infection (HIV-1 or HIV-2 antibodies).
4. Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.
5. Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.
6. Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.
7. Patient has undergone radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment.
8. Patient is unable to provide informed consent.
9. Patient has received a prior stem cell or bone marrow transplant.
10. Patient with abnormal cachexia.
11. Patient with distended abdomen from ascites.
12. Patient is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks prior to the anticipated first dose of study treatment in this study.

Where this trial is running

Kota Bharu and 3 other locations

• Hosp. Universiti Sains Malaysia (HUSM), Kelantan — Kota Bharu, Malaysia (Recruiting)
• Beacon Hospital — Kuala Lumpur, Malaysia (Recruiting)
• Hosp. Kuala Lumpur — Kuala Lumpur, Malaysia (Recruiting)
• University Malaysia Medical Centre — Kuala Lumpur, Malaysia (Recruiting)

Study contacts

• Study coordinator: Ms Munirah Jamaluddin

Conditions Advanced Solid Cancers