CompletedPhase 2

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors

Singapore14 participantsStarted 2019-09-03

Plain-language summary

This is a Phase II, open-label, single dose level study of PRL3-ZUMAB monotherapy in patients with advanced solid tumours that have failed standard therapy. Approximately 30 patients will be recruited with \~10 gastric cancers and \~10 hepatocellular carcinomas. Patients who have received at least 1 dose of PRL3-ZUMAB will be evaluable for toxicity and efficacy. PRL3-ZUMAB will be given IV every 2 weeks for up to 12 infusions in the absence of unmanageable toxicities or disease progression. Patients who are benefitting from the treatment may continue on PRL3-ZUMAB beyond 12 infusions with the agreement of the study drug provider. PRL3-ZUMAB at the RP2D in tumour types enriched for known PRL-3 expression for efficacy and tolerability will be evaluated. There will also be in depth molecular profiling of tissues in patients who have an objective response or prolonged disease stabilization to identify predictive/selection biomarkers as well as evaluation of the oncogenic signaling modulation and immunomodulation by PRL3-ZUMAB and its potential for future combination with other targeted therapies or immunotherapy.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 spermi…

What they're measuring

Objective response rate

Timeframe: From start of treatment to first occurence of disease progression or death, up to 2 years

Number of patients that do not have disease progression at 16 weeks from start of treatment

Timeframe: 16 weeks after start of treatment

Treatment related adverse events rate

Timeframe: From start of treatment to 30 days after last dose of study drug

Trial details

NCT IDNCT04118114

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-17

View on ClinicalTrials.gov More Gastric Cancer trials