PRL3-zumab treatment for advanced solid cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: munirah.jamaluddin@myxmo.com.my
• Phone: +603-4041 2821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.