Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors

Launched by NATIONAL CANCER CENTRE, SINGAPORE · Oct 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PRL3-ZUMAB for patients with advanced solid tumors, specifically gastric cancer and liver cancer, that have not responded to standard therapies. The trial aims to find out if this treatment is safe and effective. About 30 patients will be enrolled, and they will receive PRL3-ZUMAB through an IV (a small tube inserted into a vein) every two weeks for up to 12 times. If patients are benefiting from the treatment, they may continue receiving it beyond that number of infusions with permission from the study team.

To be eligible for this trial, you need to be at least 21 years old and have advanced solid tumors that have not improved after receiving standard treatments. You should also be able to perform daily activities with some assistance if needed and have a life expectancy of at least four months. Participants will be monitored closely for any side effects and how well the treatment works. Additionally, researchers will analyze tissue samples to better understand how this treatment affects the cancer and to identify potential combinations with other therapies in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients 21 years of age or older at the time written informed consent is obtained.
• • Histopathological- or cytological- documented advanced curatively unresectable solid tumors failing standard therapy.
• • For HCC must have failed at least 1 line of standard therapy.
• • For gastric cancer must have failed at least 2 line of standard therapy (inclusive of adjuvant treatment).
• • For other solid tumours must have failed at least 1 line of standard therapy.
• • Progressive disease following the last treatment
• • Life expectancy ≥ 4 months
• • Eastern Cooperative Oncology Group (ECOG) performance status (ECOG PS) score of ≤ 2 at study entry
• • Recovery to Grade ≤ 1 by the Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE v 4.03), from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for cancer, with the exception of non-clinically significant adverse events such as alopecia; biochemical abnormalities, or resolved to Grade ≤ 2: peripheral neuropathy; hypertension and proteinuria.
• • Women of childbearing potential (WOCBP) must have a negative pregnancy test at study entry. Subjects not considered WOCBP are those without menses for 24 consecutive months, and those who have undergone hysterectomy and/or bilateral salpingo-oophorectomy. WOCBP must be willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.
• * Adequate organ and hematological function as evidenced by the following laboratory studies within 10 days of 1st treatment:
• • Absolute neutrophil count ≥ 1.0 x 10\^9/L.
• • Platelet count ≥ 75 x 10\^9/L. Hemoglobin ≥ 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 ≤ 3 x ULN (≤ 5x ULN in the presence of liver mets).
• • For patients with hepatocellular carcinoma (HCC) Child Pugh score of ≤ B7.
• • Creatinine \< 1.5x ULN
• • Evaluable or measurable disease by RECIST v1.1
• • Patients with active Hepatitis B (defined as Hep B S Ag or DNA positive) need to be on anti-viral therapy while on PRL3-ZUMAB.
• Exclusion Criteria:
• • Untreated or symptomatic central nervous system metastases. Patients with treated brain metastases stable for 3 months are eligible to enroll.
• • Major surgical procedures within 28 days prior to enrolment.
• • Pregnant or breast-feeding females.
• • Known HIV infection.
• * Treatment with any of the following anti-cancer therapies prior to the first dose of study drugs within the stated time frames:
• • Prior chemotherapy ≤ 2 weeks of C1 Day 1 of PRL3-ZUMAB.
• • Biological therapy (e.g., antibodies) within a period of time that is ≤ 5 t1/2 or ≤ 3 weeks, whichever is shorter, prior to starting study drug.
• • Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 3 weeks (whichever is shorter) prior to starting study drug.
• • Any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug.
• • Wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug.
• • Patients requiring regular immunosuppressive medication for autoimmune disease or corticosteroid doses of \>10mg prednisolone for greater than 2 days
• • Unable to provide informed consent.
• • History of another cancer within the last 2 years, with the exception of
• • Curatively resected non-melanomatous skin cancer,
• • Curatively treated cervical carcinoma in-situ,
• • Prostate cancer treated with leuteinizing hormone-releasing hormone (LH-RH) agonists/pure antagonists for at least 2 months
• • Prior stem cell or bone marrow transplant
• • Vaccinated within 2 weeks from prior to the first administration of PRL3-ZUMAB