PRL3-Zumab in Patients With Advanced Solid Tumors

NCT07541001 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 226688-C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Advanced Malignant Solid Tumor

Keywords

PRL3-zumab; Phase II China Trial

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 (2)

• 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.

• Objective Response Rate (ORR)

  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)

PRL3-zumab treated arm

EXPERIMENTAL

6mg/kg of PRL3-zumab will be administered

Biological: PRL3-ZUMAB

Interventions

PRL3-ZUMAB BIOLOGICAL

PRL3-zumab is an humanized anti PRL3 antibody targeted to PRL3 antigen in cancer cells

PRL3-zumab treated arm

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

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 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
• 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.

Sponsors & Collaborators

• Intra-IMMUSG Pte Ltd: lead
• The First Affiliated Hospital of Xiamen University: collaborator
• Shanghai Chest Hospital: collaborator
• Hubei Cancer Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• Hangzhou Cancer Hospital: collaborator

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, China

Location

Related Links

• PRL3-zumab Phase II US trial
• PRL3-zumab Phase I (Singapore) trial
• PRL3-zumab First-in-Pediatric compassionate trial

Study Officials

• Prof Qi Zeng

  Intra-IMMUSG Pte Ltd

  STUDY DIRECTOR

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: April 15, 2026
• First Posted: April 21, 2026
• Study Start: August 30, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)