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Gastric CancerPhase 2NCT04118114

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors

A Phase 2 study testing PRL3-zumab in people with Gastric Cancer and Hepatocellular Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
PRL3-zumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSingapore
Study dates
3 Sep 2019to 17 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Center Singapore

    Singapore, 169690

Other trials in Singapore

About this study

Official title: An Open Label Phase II Study of the Efficacy and Tolerability of PRL3-ZUMAB and Predictive Biomarkers in Advanced Solid Tumours

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.

Being tested
PRL3-zumab
Medical subject headings
Stomach Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRL3-zumabDrug

    IV administration every 2 weeks

Study groups in NCT04118114
Study groupRoleWhat they receive
PRL3-ZUMAB MonotherapyExperimentalNot described
Receives: Drug: PRL3-zumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

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

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

    Clinical benefit rate at 16 weeks

    Measured: 16 weeks after start of treatment

  3. Treatment related adverse events rate

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start3 Sep 2019
  3. Primary completion17 Oct 2025
  4. Study completion17 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04118114
Sponsor's protocol ID
NCCS-2018-Phase2-PRL3
Status last verified
Apr 2026
First submitted
4 Oct 2019
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thura M, Al-Aidaroos AQO, Yong WP, Kono K, Gupta A, Lin YB, Mimura K, Thiery JP, Goh BC, Tan P, Soo R, Hong CW, Wang L, Lin SJ, Chen E, Rha SY, Chung HC, Li J, Nandi S, Yuen HF, Zhang SD, Guan YK, So J, Zeng Q. PRL3-zumab, a first-in-class humanized antibody for cancer therapy. JCI Insight. 2016 Jun 16;1(9):e87607. doi: 10.1172/jci.insight.87607.

    PubMed 27699276

  • Guo K, Li J, Tang JP, Tan CP, Hong CW, Al-Aidaroos AQ, Varghese L, Huang C, Zeng Q. Targeting intracellular oncoproteins with antibody therapy or vaccination. Sci Transl Med. 2011 Sep 7;3(99):99ra85. doi: 10.1126/scitranslmed.3002296.

    PubMed 21900592

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRL3-zumab in people with Gastric Cancer and Hepatocellular Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From start of treatment to first occurence of disease progression or death, up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04118114, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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