Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients

NCT07290088 | Recruiting Phase 2 DMC

• 1 other identifier: 226688-M
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Multi-Center, Phase II/III, open-label, single dose level (6 mg/kg) basket trial of PRL3-zumab monotherapy in solid cancer patients. The study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1/2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up/EOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit. PRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.

Conditions

Advanced Solid Cancers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.

Secondary Outcomes (1)

• Clinical benefit rate (CBR)

  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.

Study Arms (1)

Experimental: PRL3-ZUMAB Monotherapy

OTHER

Single Arm

Biological: PRL3-ZUMAB

Interventions

PRL3-ZUMAB BIOLOGICAL

PRL3-zumab will be administered every 2-week/dose till patient progress or develops intolerable toxicity or withdraw consent. A dose at 10-days is allowed at the first 4 doses when patients had heavier tumor burden since PRL3-zumab PK t ½ = 12 days (±2 days).

Experimental: PRL3-ZUMAB Monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 - 75 years with solid tumors
• Willing to provide written informed consent for the study.
• Histopathological diagnosis and metastatic status cancer at study entry.
• Stage 1-3 patients with no more than 3 prior lines of treatment
• Life expectancy of more than 6 months (especially for Pancreatic cancer patients).
• 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
• 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.
• Platelet count ≥ 75 x 109/L. Hemoglobin ≥ 90 g/L (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.

You may not qualify if:

• 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 has known history of human immunodeficiency virus (HIV) infection (HIV-1 or HIV-2 antibodies).
• 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 is unable to provide informed consent.
• Patient has received a prior stem cell or bone marrow transplant.
• Patient with abnormal cachexia.
• Patient with distended abdomen from ascites.
• 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.

Sponsors & Collaborators

• Intra-IMMUSG Pte Ltd: lead
• Kuala Lumpur General Hospital: collaborator
• Beacon Hospital: collaborator
• Hospital Universiti Sains Malaysia: collaborator
• University Malaysia Medical Centre: collaborator

Study Sites (4)

Hosp. Universiti Sains Malaysia (HUSM), Kelantan

Kota Bharu, Malaysia

RECRUITING

Beacon Hospital

Kuala Lumpur, Malaysia

RECRUITING

Hosp. Kuala Lumpur

Kuala Lumpur, Malaysia

RECRUITING

University Malaysia Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

Related Publications (7)

• 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.

  PMID: 40345181 BACKGROUND

• Loh AHP, Thura M, Gupta A, Tan SH, Kuan KKY, Ang KH, Merchant K, Chang KTE, Yon HY, Chen Y, Cheng MHW, Mahadev A, Ng MCH, Seng MS, Iyer P, Chia PL, Soh SY, Zeng Q. Exploiting frequent and specific expression of PRL3 in pediatric solid tumors for first-in-child use of PRL3-zumab humanized antibody. Mol Ther Oncolytics. 2023 Aug 18;30:153-166. doi: 10.1016/j.omto.2023.08.006. eCollection 2023 Sep 21.

  PMID: 37674627 BACKGROUND

• Chee CE, Ooi M, Lee SC, Sundar R, Heong V, Yong WP, Ng CH, Wong A, Lim JSJ, Tan DSP, Soo R, Tan JTC, Yang S, Thura M, Al-Aidaroos AQ, Chng WJ, Zeng Q, Goh BC. A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies. Target Oncol. 2023 May;18(3):391-402. doi: 10.1007/s11523-023-00962-w. Epub 2023 Apr 15.

  PMID: 37060431 BACKGROUND

• Thura M, Ye Z, Al-Aidaroos AQ, Xiong Q, Ong JY, Gupta A, Li J, Guo K, Ang KH, Zeng Q. PRL3 induces polypoid giant cancer cells eliminated by PRL3-zumab to reduce tumor relapse. Commun Biol. 2021 Jul 29;4(1):923. doi: 10.1038/s42003-021-02449-8.

  PMID: 34326464 BACKGROUND

• Thura M, Al-Aidaroos AQ, Gupta A, Chee CE, Lee SC, Hui KM, Li J, Guan YK, Yong WP, So J, Chng WJ, Ng CH, Zhou J, Wang LZ, Yuen JSP, Ho HSS, Yi SM, Chiong E, Choo SP, Ngeow J, Ng MCH, Chua C, Yeo ESA, Tan IBH, Sng JXE, Tan NYZ, Thiery JP, Goh BC, Zeng Q. PRL3-zumab as an immunotherapy to inhibit tumors expressing PRL3 oncoprotein. Nat Commun. 2019 Jun 6;10(1):2484. doi: 10.1038/s41467-019-10127-x.

  PMID: 31171773 BACKGROUND

• 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.

  PMID: 27699276 BACKGROUND

• 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.

  PMID: 21900592 BACKGROUND

Study Officials

• Prof Qi Zeng

  Intra-IMMUSG Pte Ltd

  STUDY DIRECTOR

Central Study Contacts

Ms Munirah Jamaluddin

CONTACT

+603-4041 2821; munirah.jamaluddin@myxmo.com.my

Dr Min Thura

CONTACT

min.thura@intra-immusg.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 17, 2025
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)