Advanced Malignant Solid TumorPhase 2China Phase IINCT07541001
PRL3-Zumab in Patients With Advanced Solid Tumors
A Phase 2 study testing PRL3-ZUMAB in people with Advanced Malignant Solid Tumor, run by Intra-IMMUSG Pte Ltd at 1 site in China.
Trial summary
This is a multicenter, Phase II, open-label, single-dose-level (6 mg/kg) study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumors. PRL3-zumab will be administered via intravenous (IV) infusion until discontinuation criteria are met (e.g., disease progression per RECIST v1.1/iRECIST… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- PRL3-ZUMAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2021to 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
- Men and women aged 18 or older with unresectable or metastatic solid tumors
- Patients with locally advanced or metastatic solid tumors who have failed standard therapy or for whom no standard therapy is available. Treatment failure is defined as disease progression during or after systemic antitumor therapy (including but not limited to chemotherapy, radiotherapy, biologic therapy, immunotherapy, and endocrine therapy), or intolerance to treatment-related toxicities. Disease progression must be documented by radiographic evidence or clinical evidence. For patients who have received adjuvant or neoadjuvant therapy (radiotherapy or chemoradiotherapy), disease progression occurring during treatment or after completion of such therapy will be considered treatment failure.
- Willing to provide written informed consent for the study.
- Histopathological diagnosis and metastatic status cancer at study entry.
- Must have received no more than 3 prior lines of treatment for metastatic disease.
- Life expectancy of more than 6 months
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Patient should have recovered from toxicity of prior treatment regimen to Grade 1 level except for alopecia or peripheral neuropathy or fatigue as defined by Common Terminology Criteria for Adverse Events (CTCAE version 5.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at study entry and must follow highly effective contraception
- WOCBP must be willing to use highly effective methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide,) for the duration of the study and 90 days thereafter.
- Male participants should take precaution to avoid pregnancy in sexual partner during the study and 90 days thereafter.
- Adequate organ and hematological function as evidenced by the following laboratory studies within 10 days of treatment:
- Absolute neutrophil count ≥ 1.0 x 109/L to 8.0 × 10⁹/L.
- Lymphocyte count ≥ 0.9 × 10⁹/L
- Platelet count ≥ 75 x 109/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 ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in the presence of liver metastases).
- For patients with hepatocellular carcinoma (HCC) Child Pugh score of ≤ B7.
- Creatinine < 1.5x ULN. Creatinine clearance (according to Cockcroft-Gault Equation or by 24-hour urine collection) of > 60 mL/min at study entry.
- According to RECIST 1.1 and iRECIST, patients mush have at least one measurable lesion that meets the following criteria: Accurately measureable at baseline. Longest diameter ≥10mm at baseline (for lymph nodes, short axis ≥ 15mm). Measurable by a reproducible imaging method such as computed tomography (CT) or magnetic resonance imaging (MRI). If only one measurable lesion is present, it must not have been previously treated with local therapy such as radiotherapy.
Who cannot join
- Patient has known untreated or symptomatic central nervous system metastasis.
- Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.
- Patient with any of the following virologic findings:
- Positive hepatitis B surface antigen (HBsAg) and positive HBV DNA
- Positive anti-HIV antibody and positive HCV RNA
- Positive HIV antibody
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- Patients with active autoimmune disease requiring systemic treatment, or with a history of autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis), or patients at high risk (e.g., prior organ transplantation requiring immunosuppressive therapy).
- Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment 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 or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment.
- Patient has received > 3 lines of prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant chemotherapy treatment completed at least 1-year prior is not to be included in this).
- Patient is unable to provide informed consent.
- Patient has a history of another active cancer (which requires treatment and not considered cured by the investigator) within the last 2 years.
- Patient has received a prior stem cell or bone marrow transplant.
- Patient has received a live vaccine within 12 weeks of the first dose of PRL3-zumab. (Seasonal influenza vaccines that do not contain live virus are permitted).
- Patient is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks prior to the anticipated first dose of study treatment in this study.
- Patients with spinal cord compression caused by tumor, unless the condition has been treated and clinically stable for more than 1 month.
- Patients with any unstable medical condition or any other disease that may compromise their safety or compliance with the study, including any severe or uncontrolled systemic disease such as uncontrolled hypertension, uncontrolled diabetes mellitus, or active bleeding.
- Patients with alcohol dependence or a history of drug abuse or substance abuse within 1 year prior to study entry.
- Patients with any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality, that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results.
- Patients who, in the investigator's judgment, are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Multicenter, Safety and Efficacy Phase II Study of PRL3-Zumab in Solid Tumors
This is a multicenter, Phase II, open-label, single-dose-level (6 mg/kg) study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumors. PRL3-zumab will be administered via intravenous (IV) infusion until discontinuation criteria are met (e.g., disease progression per RECIST v1.1/iRECIST, intolerable toxicity, or withdrawal of consent).
Study Periods and Duration
Read more
The study is divided into the following phases:
- Screening Period: Day -21 to Day -1; all assessments must be completed prior to the first dose.
- Treatment Period: One cycle is defined as 4 weeks, consisting of two infusions administered 2 weeks apart.
- End-of-Treatment (EOT) Visit: To be conducted within 14 days of the last dose or treatment discontinuation.
- Safety Follow-Up: A visit scheduled 30 days after the last dose.
- Survival Follow-Up: Conducted every 3 months post-discontinuation via telephone or other appropriate methods until the data cutoff date.
Assessments
- Safety \& QoL: Safety assessments (including laboratory tests) will be performed prior to each infusion. Quality of Life (QoL) will be assessed at screening and every 8 weeks during treatment.
- Tumor Imaging: Assessments will be performed at baseline and every 8 weeks following the initiation of study treatment, according to RECIST v1.1 and iRECIST.
- Immunogenicity: Assessments will be performed pre-dose on Cycle 1 Day 1, and prior to infusions in Cycles 2, 4, and 6. For patients remaining on treatment, assessments will continue every 3 cycles thereafter.
Pharmacokinetic (PK) profiles will be evaluated in two distinct subgroups of 10 patients each. For the intensive PK sampling subgroup, assessments are concentrated in the first three cycles: Cycle 1 monitoring includes Day 1 (pre-dose, end of infusion, 2, and 6 hours post-infusion), Day 2 (24 hours), Day 6 (120 hours), Day 10 (216 hours), and Day 15 (pre-dose). Following pre-dose samples on Cycle 2 (Days 1 and 15) and Cycle 3 (Day 1), a second intensive window occurs on Cycle 3 Day 15 (pre-dose, end of infusion, 2, and 6 hours post-infusion) and continues through Days 16, 20, and 24. Subsequent samples are taken pre-dose on Day 1 of Cycles 4, 5, and 6, concluding at the EOT visit. In contrast, the sparse PK sampling subgroup will undergo limited assessments at Cycle 1 Day 1 (pre-dose and end of infusion), Cycle 1 Day 15 (pre-dose), and the first day of Cycles 2 and 3 (pre-dose and end of infusion), with a final sample collected at the EOT visit.
Read the detailed description
Study Assessments
Efficacy:
Efficacy will be evaluated by the investigator using RECIST v1.1 and iRECIST criteria. Tumor evaluations, including contrast-enhanced computed tomography (CT) scans, will be performed at baseline (within 14 days prior to Cycle 1 Day 1) and every 56 days thereafter. Magnetic resonance imaging (MRI) may be used if a patient is ineligible for CT scans; however, the same imaging modality must be used consistently throughout the study.
Safety:
Patient safety will be assessed on an ongoing basis during each cycle. Evaluations include physical examinations, vital signs (systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature), and clinical laboratory tests (hematology, clinical chemistry, and coagulation). Adverse events (AEs) will be graded according to CTCAE v5.0.
Pharmacokinetics (PK):
Blood samples for PK analysis will be collected as follows:
- Intensive Sampling Group (N=10): C1D1 (pre-dose, EOI, 2h, and 6h post-infusion), C1D2 (24h), C1D6 (120h), C1D10 (216h), C1D15 (pre-dose); C2D1 and C2D15 (pre-dose); C3D1 (pre-dose), C3D15 (pre-dose, EOI, 2h, and 6h post-infusion), C3D16 (24h), C3D20 (120h), C3D24 (216h); C4D1, C5D1, C6D1 (pre-dose), and at End of Treatment (EOT).
- Sparse Sampling Group: C1D1 (pre-dose, EOI), C1D15 (pre-dose); C2D1 and C3D1 (pre-dose and EOI), and at EOT.
Immunogenicity \& Quality of Life (QoL) Anti-drug antibody (ADA) samples will be collected prior to infusion on C1D1 and Cycles 2, 4, and 6. Thereafter, samples will be collected every three months. Neutralizing antibody assessments will be performed for any patient testing positive for ADA.
Quality of Life (QoL) will be measured using EQ-5D and EORTC-QLQ-C30 questionnaires at screening and every 2 cycles (8 weeks ± 2 days for C1-C4; 8 weeks ± 7 days thereafter).
Study Duration and Periods
- Cycle Period: One cycle is 28 days (two infusions administered 2 weeks apart).
- Treatment Period: Treatment continues until disease progression (per RECIST 1.1/iRECIST or clinical criteria), intolerable toxicity, or withdrawal of consent.
- Follow-up Period: Includes a Safety Follow-up (30 ± 7 days after the last dose or prior to new therapy) and a Survival Follow-up (every 3 months via telephone until the data cutoff date, which is 24 weeks after the last subject's enrollment).
Statistical Considerations
Sample Size and Populations:
This is an exploratory trial; thus, the sample size is not based on formal hypothesis testing. A total of 50 subjects will be enrolled, with approximately 30 evaluable subjects expected for PFS and TTP assessments. Patients receiving fewer than 4 doses or lacking at least one post-baseline assessment will be replaced.
Analysis Sets:
- Safety Set (SS): All patients receiving dose of study treatment.
- Full Analysis Set (FAS): All patients receiving dose with measurable lesions at baseline.
- Per Protocol Set (PPS): A subset of the FAS excluding those with major protocol deviations.
- Evaluable Population Set (EPS): FAS patients with evaluable post-baseline tumor assessment.
- PK/ADA Sets: Patients with dose and valid post-baseline PK/ADA measurements.
Statistical Methods:
Analyses will be performed using SAS® v9.4 or later. Categorical variables will be summarized by frequency/percentage, and continuous variables by descriptive statistics (mean, SD, median, range).
- Efficacy: The primary endpoints, Progression-Free Survival (PFS) and Time to Progression (TTP), will be analyzed using Kaplan-Meier methods. Secondary endpoints (ORR, CBR) will include 95% confidence intervals (Clopper-Pearson).
- Pharmacokinetics: PK parameters will be summarized descriptively. A population PK model will be developed.
- Safety: TEAEs and treatment-related AEs (TRAEs) will be summarized by System Organ Class (SOC) and Preferred Term (PT). Laboratory and vital sign changes from baseline will be summarized descriptively.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- PRL3-ZUMAB
- Keywords
- PRL3-zumab, Phase II China Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRL3-ZUMABBiological
PRL3-zumab is an humanized anti PRL3 antibody targeted to PRL3 antigen in cancer cells
| Study group | Role | What they receive |
|---|---|---|
| PRL3-zumab treated arm | Experimental | 6mg/kg of PRL3-zumab will be administered Receives: Biological: PRL3-ZUMAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.
Time to Progression (TTP)
TTP is defined as the time from the the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria which does not include deaths.
Measured: From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.
Secondary outcomes (2)
Clinical benefit rate (CBR)
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 date of first dose of study drug until first documented disease progression or date of death, whichever comes first, assessed at every 8 weeks up to 48 weeks.
Objective Response Rate (ORR)
CBR is defined as the percentage of patients with CR or PR as per RECIST v1.1 and iRECIST criteria based on Investigator's assessment.
Measured: Time Frame: From date of first dose of study drug until first documented disease progression or date of death, whichever comes first, assessed at every 8 weeks up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Aug 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-IMMUSG Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Xiamen University, Shanghai Chest Hospital, Hubei Cancer Hospital, Henan Cancer Hospital, Beijing Friendship Hospital, Fujian Provincial Hospital, Hangzhou Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Prof Qi Zeng, Study director, Intra-IMMUSG Pte Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541001
- Sponsor's protocol ID
- 226688-C
- Acronym
- China Phase II
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for IPD can be submitted by email to min.thura@intra-immusg.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Safety and Efficacy Phase II Study of PRL3-Zumab in Solid Tumors
- ClinicalTrials.gov ID
- NCT07541001
- Acronym / sponsor ID
- China Phase II / 226688-C
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- PRL3-zumab, Phase II China Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Intra-IMMUSG Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Xiamen University, Shanghai Chest Hospital, Hubei Cancer Hospital, Henan Cancer Hospital, Beijing Friendship Hospital, Fujian Provincial Hospital, Hangzhou Cancer Hospital
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, Phase II, open-label, single-dose-level (6 mg/kg) study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumors. PRL3-zumab will be administered via intravenous (IV) infusion until discontinuation criteria are met (e.g., disease progression per RECIST v1.1/iRECIST, intolerable toxicity, or withdrawal of consent).
Study Periods and Duration
The study is divided into the following phases:
- Screening Period: Day -21 to Day -1; all assessments must be completed prior to the first dose.
- Treatment Period: One cycle is defined as 4 weeks, consisting of two infusions administered 2 weeks apart.
- End-of-Treatment (EOT) Visit: To be conducted within 14 days of the last dose or treatment discontinuation.
- Safety Follow-Up: A visit scheduled 30 days after the last dose.
- Survival Follow-Up: Conducted every 3 months post-discontinuation via telephone or other appropriate methods until the data cutoff date.
Assessments
- Safety \& QoL: Safety assessments (including laboratory tests) will be performed prior to each infusion. Quality of Life (QoL) will be assessed at screening and every 8 weeks during treatment.
- Tumor Imaging: Assessments will be performed at baseline and every 8 weeks following the initiation of study treatment, according to RECIST v1.1 and iRECIST.
- Immunogenicity: Assessments will be performed pre-dose on Cycle 1 Day 1, and prior to infusions in Cycles 2, 4, and 6. For patients remaining on treatment, assessments will continue every 3 cycles thereafter.
Pharmacokinetic (PK) profiles will be evaluated in two distinct subgroups of 10 patients each. For the intensive PK sampling subgroup, assessments are concentrated in the first three cycles: Cycle 1 monitoring includes Day 1 (pre-dose, end of infusion, 2, and 6 hours post-infusion), Day 2 (24 hours), Day 6 (120 hours), Day 10 (216 hours), and Day 15 (pre-dose). Following pre-dose samples on Cycle 2 (Days 1 and 15) and Cycle 3 (Day 1), a second intensive window occurs on Cycle 3 Day 15 (pre-dose, end of infusion, 2, and 6 hours post-infusion) and continues through Days 16, 20, and 24. Subsequent samples are taken pre-dose on Day 1 of Cycles 4, 5, and 6, concluding at the EOT visit. In contrast, the sparse PK sampling subgroup will undergo limited assessments at Cycle 1 Day 1 (pre-dose and end of infusion), Cycle 1 Day 15 (pre-dose), and the first day of Cycles 2 and 3 (pre-dose and end of infusion), with a final sample collected at the EOT visit.
Detailed description
Study Assessments
Efficacy:
Efficacy will be evaluated by the investigator using RECIST v1.1 and iRECIST criteria. Tumor evaluations, including contrast-enhanced computed tomography (CT) scans, will be performed at baseline (within 14 days prior to Cycle 1 Day 1) and every 56 days thereafter. Magnetic resonance imaging (MRI) may be used if a patient is ineligible for CT scans; however, the same imaging modality must be used consistently throughout the study.
Safety:
Patient safety will be assessed on an ongoing basis during each cycle. Evaluations include physical examinations, vital signs (systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature), and clinical laboratory tests (hematology, clinical chemistry, and coagulation). Adverse events (AEs) will be graded according to CTCAE v5.0.
Pharmacokinetics (PK):
Blood samples for PK analysis will be collected as follows:
- Intensive Sampling Group (N=10): C1D1 (pre-dose, EOI, 2h, and 6h post-infusion), C1D2 (24h), C1D6 (120h), C1D10 (216h), C1D15 (pre-dose); C2D1 and C2D15 (pre-dose); C3D1 (pre-dose), C3D15 (pre-dose, EOI, 2h, and 6h post-infusion), C3D16 (24h), C3D20 (120h), C3D24 (216h); C4D1, C5D1, C6D1 (pre-dose), and at End of Treatment (EOT).
- Sparse Sampling Group: C1D1 (pre-dose, EOI), C1D15 (pre-dose); C2D1 and C3D1 (pre-dose and EOI), and at EOT.
Immunogenicity \& Quality of Life (QoL) Anti-drug antibody (ADA) samples will be collected prior to infusion on C1D1 and Cycles 2, 4, and 6. Thereafter, samples will be collected every three months. Neutralizing antibody assessments will be performed for any patient testing positive for ADA.
Quality of Life (QoL) will be measured using EQ-5D and EORTC-QLQ-C30 questionnaires at screening and every 2 cycles (8 weeks ± 2 days for C1-C4; 8 weeks ± 7 days thereafter).
Study Duration and Periods
- Cycle Period: One cycle is 28 days (two infusions administered 2 weeks apart).
- Treatment Period: Treatment continues until disease progression (per RECIST 1.1/iRECIST or clinical criteria), intolerable toxicity, or withdrawal of consent.
- Follow-up Period: Includes a Safety Follow-up (30 ± 7 days after the last dose or prior to new therapy) and a Survival Follow-up (every 3 months via telephone until the data cutoff date, which is 24 weeks after the last subject's enrollment).
Statistical Considerations
Sample Size and Populations:
This is an exploratory trial; thus, the sample size is not based on formal hypothesis testing. A total of 50 subjects will be enrolled, with approximately 30 evaluable subjects expected for PFS and TTP assessments. Patients receiving fewer than 4 doses or lacking at least one post-baseline assessment will be replaced.
Analysis Sets:
- Safety Set (SS): All patients receiving dose of study treatment.
- Full Analysis Set (FAS): All patients receiving dose with measurable lesions at baseline.
- Per Protocol Set (PPS): A subset of the FAS excluding those with major protocol deviations.
- Evaluable Population Set (EPS): FAS patients with evaluable post-baseline tumor assessment.
- PK/ADA Sets: Patients with dose and valid post-baseline PK/ADA measurements.
Statistical Methods:
Analyses will be performed using SAS® v9.4 or later. Categorical variables will be summarized by frequency/percentage, and continuous variables by descriptive statistics (mean, SD, median, range).
- Efficacy: The primary endpoints, Progression-Free Survival (PFS) and Time to Progression (TTP), will be analyzed using Kaplan-Meier methods. Secondary endpoints (ORR, CBR) will include 95% confidence intervals (Clopper-Pearson).
- Pharmacokinetics: PK parameters will be summarized descriptively. A population PK model will be developed.
- Safety: TEAEs and treatment-related AEs (TRAEs) will be summarized by System Organ Class (SOC) and Preferred Term (PT). Laboratory and vital sign changes from baseline will be summarized descriptively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRL3-zumab treated arm | Experimental | Biological: PRL3-ZUMAB6mg/kg of PRL3-zumab will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Men and women aged 18 or older with unresectable or metastatic solid tumors
- Patients with locally advanced or metastatic solid tumors who have failed standard therapy or for whom no standard therapy is available. Treatment failure is defined as disease progression during or after systemic antitumor therapy (including but not limited to chemotherapy, radiotherapy, biologic therapy, immunotherapy, and endocrine therapy), or intolerance to treatment-related toxicities. Disease progression must be documented by radiographic evidence or clinical evidence. For patients who have received adjuvant or neoadjuvant therapy (radiotherapy or chemoradiotherapy), disease progression occurring during treatment or after completion of such therapy will be considered treatment failure.
- Willing to provide written informed consent for the study.
- Histopathological diagnosis and metastatic status cancer at study entry.
- Must have received no more than 3 prior lines of treatment for metastatic disease.
Key exclusion criteria (22 listed)
- Patient has known untreated or symptomatic central nervous system metastasis.
- Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.
- Patient with any of the following virologic findings:
- Patients with active autoimmune disease requiring systemic treatment, or with a history of autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis), or patients at high risk (e.g., prior organ transplantation requiring immunosuppressive therapy).
- Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRL3-ZUMABPRL3-zumab is an humanized anti PRL3 antibody targeted to PRL3 antigen in cancer cells | Biological | PRL3-zumab treated arm |
Primary outcome
Progression free survival (PFS)
Time frame: Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.
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.
Time to Progression (TTP)
Time frame: From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.
TTP is defined as the time from the the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria which does not include deaths.
2 secondary outcomes
Clinical benefit rate (CBR)
Time frame: Time Frame: From date of first dose of study drug until first documented disease progression or date of death, whichever comes first, assessed at every 8 weeks up to 48 weeks.
Objective Response Rate (ORR)
Time frame: Time Frame: From date of first dose of study drug until first documented disease progression or date of death, whichever comes first, assessed at every 8 weeks up to 48 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- PRL3-zumab Phase II US trialLink provided by the sponsor.
- PRL3-zumab Phase I (Singapore) trialLink provided by the sponsor.
- PRL3-zumab First-in-Pediatric compassionate trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Requests for IPD can be submitted by email to min.thura@intra-immusg.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Qi Zeng study director
Intra-IMMUSG Pte Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRL3-ZUMAB in people with Advanced Malignant Solid Tumor, run by Intra-IMMUSG Pte Ltd at 1 site in China.
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 22 inclusion and 22 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 23 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 1 site in China. 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: Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.