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Solid TumorPhase 2NCT04452955

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors

A Phase 2 study testing PRL3-zumab in people with Solid Tumor, run by Intra-IMMUSG Pte Ltd at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
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
51 participants
Where
5 sitesUnited States
Study dates
12 Dec 2020to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Patients with unresectable or metastatic solid tumors willing to provide signed informed consent.
  • Histopathological diagnosis and metastatic status cancer at study entry.
  • Must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease.
  • Life expectancy of more than 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than 2.
  • Adequate organ and hematological function.
  • Measurable disease by RECIST v1.1 and iRECIST.

Who cannot join

  • Patient has known untreated or symptomatic central nervous system metastasis.
  • Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition.
  • Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.
  • Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.
  • Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment.
  • Patient has received > 3 lines of prior systemic chemotherapy for metastatic disease

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • St. Jude Medical Center

    Fullerton, California, 92835

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89014

  • The Angeles Clinic

    Los Angeles, California, 90025

  • Norton Healthcare

    Louisville, Kentucky, 40200

  • HonorHealth Research

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

Read the detailed description

The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).

Conditions
Solid Tumor
Being tested
PRL3-zumab
Keywords
PRL-3, Tumor, Efficacy, Safety, Pharmacokinetics
Medical subject headings
Neoplasms

What participants receive

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

  • PRL3-zumabBiological

    Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)

Study groups in NCT04452955
Study groupRoleWhat they receive
PRL3-zumabExperimentalAll patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.
Receives: Biological: PRL3-zumab

What is being measured

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

  1. Progression free survival (PFS)

    PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.

    Measured: From first dose of study drug until disease progression or end of treatment, whichever comes first

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    Description: ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 and iRECIST criteria from time of initiation of study treatment.

    Measured: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first.

  2. Clinical benefit rate (CBR)

    Description: CBR is defined as the percentage of patients with CR, PR, or stable disease (SD) as per RECIST v1.1 and iRECIST criteria based on Investigator's assessment.

    Measured: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first

  3. Overall survival (OS)

    Description: OS is defined as the time from the initiation of study treatment to death from any cause.

    Measured: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first

  4. Duration of response

    Description: Duration of response is defined as the time from the initial documented response (CR or PR) to the first documented sign of disease progression as per RECIST v1.1 and iRECIST criteria or death.

    Measured: Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first

  5. Terminal elimination half life (t½)

    To assess PK after single and multiple dose administration of PRL3-zumab.

    Measured: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.

  6. Maximum plasma PRL3-zumab concentration (Cmax)

    To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab.

    Measured: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.

  7. Time of Cmax (tmax)

    To assess PK after single and multiple dose administration of PRL3-zumab.

    Measured: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.

  8. Area under the concentration time curve from pre-dose (AUCinf)

    To assess PK after single and multiple dose administration of PRL3-zumab.

    Measured: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.

  9. Number of patients with adverse events and serious adverse events

    To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.

    Measured: From first dose of study drug until disease progression or end of treatment, whichever comes first

  10. European Quality-5D (EQ-5D)

    The system comprises 5 questions, 1 for each of 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each is rated according to 3 response levels ("no problems," "some problems," or "extreme problems").

    Measured: From first dose of study drug until disease progression or end of treatment, whichever comes first

  11. European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)

    Health-related quality of life is measured by EORTC-QLQ-C30, a 30 item questionnaire. This scale consists of functioning scales and symptom scales. For functioning scales higher scores suggest better functioning; for symptom scales higher scores suggest higher symptom burden.

    Measured: From first dose of study drug until disease progression or end of treatment, whichever comes first

Timeline

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

  1. First posted1 Jul 2020
  2. Study start12 Dec 2020
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452955
Sponsor's protocol ID
226688
Status last verified
Nov 2025
First submitted
22 Jun 2020
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Park DJ, Thura M, Chiu VK, Vicuna B, Ang KH, Sanchez B, Chia PL, Kuan KY, Li J, Zhang K, Zheng WH, Hsien Ng MC, Zeng Q. The PRL3-zumab paradigm: A multicenter, single-dose-level phase 2 basket clinical trial design of an unconventional cancer immunotherapy. Cell Rep Med. 2025 May 20;6(5):102120. doi: 10.1016/j.xcrm.2025.102120. Epub 2025 May 8.

    PubMed 40345181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRL3-zumab in people with Solid Tumor, run by Intra-IMMUSG Pte Ltd at 5 sites in United States.

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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression free survival (PFS) (time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first). 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 NCT04452955, which also lists 1 linked publication.

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 22 Apr 2026.

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