Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04118114|
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Hepatocellular Carcinoma Advanced Solid Tumor||Drug: PRL3-zumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Study of the Efficacy and Tolerability of PRL3-ZUMAB and Predictive Biomarkers in Advanced Solid Tumours|
|Actual Study Start Date :||September 3, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: PRL3-ZUMAB Monotherapy||
IV administration every 2 weeks
- Objective response rate [ Time Frame: 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 [ Time Frame: 16 weeks after start of treatment ]Clinical benefit rate at 16 weeks
- Treatment related adverse events rate [ Time Frame: From start of treatment to 30 days after last dose of study drug ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118114
|Contact: Matthew Ng, MD||6436 email@example.com|
|National Cancer Center Singapore||Recruiting|
|Singapore, Singapore, 169690|
|Principal Investigator:||Matthew Ng, MD||National Cancer Centre of Singapore|