The PRL3-zumab paradigm: A multicenter, single-dose-level phase 2 basket clinical trial design of an unconventional cancer immunotherapy.
David J Park, Min Thura, Vi K Chiu...
https://pubmed.ncbi.nlm.nih.gov/40345181Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
ID07290088
An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients
Led by Intra-IMMUSG Pte Ltd · Updated on 2026-04-16
52
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Intra-IMMUSG Pte Ltd
Lead Sponsor
K
Kuala Lumpur General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating PRL3-zumab monotherapy in patients with advanced solid cancers in a multicenter, open-label Phase II/III trial. This study aims to assess the safety and effectiveness of a single dose level of PRL3-zumab (6 mg/kg) given intravenously every two weeks, focusing on progression-free survival and time to progression based on tumor response. The trial includes patients with stage 1-3 solid tumors who have had no more than three prior treatments and a life expectancy of more than six months. PRL3-zumab is administered by intravenous infusion every two weeks until the patient experiences disease progression, intolerable side effects, or withdraws consent. One treatment cycle consists of two infusions over four weeks, with safety assessments including laboratory tests done before each infusion. Tumor response is evaluated using iRECIST criteria at baseline and after every four doses. Quality of life questionnaires are completed at screening and every four doses during treatment. The study also includes a screening period before treatment, an end-of-treatment visit within two weeks of the last dose, a safety follow-up visit 28 days after treatment ends, and monthly survival follow-up calls for six months after the study concludes. Participants will undergo regular physical exams, vital sign monitoring, laboratory tests, and questionnaires to assess quality of life throughout the study. Safety is closely monitored using standard criteria for adverse events. The primary outcomes are progression-free survival and time to progression assessed up to 12 months after the first dose. Secondary outcomes include clinical benefit rate measured every eight weeks up to 48 weeks. The total treatment duration varies by patient depending on response and tolerance, with ongoing safety follow-up and survival monitoring for six months after treatment completion.
CONDITIONS
Brief Title
Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Recovery from prior treatment toxicity to Grade 1 level except alopecia, peripheral neuropathy, or fatigue
- Women of childbearing potential must have a negative pregnancy test and use highly effective contraception
- Adequate organ and blood function within 10 days of treatment
- Measurable disease by iRECIST
- No history of active hepatitis B or C infection
You will not qualify if you...
- Known untreated or symptomatic central nervous system metastasis
- Female patients who are pregnant, breastfeeding, or expecting to conceive during treatment and specified post-treatment periods
- Known history of HIV infection
- Receiving systemic glucocorticoids above 10 mg daily or other immunosuppressive treatments
- History of severe hypersensitivity to monoclonal antibodies
- Treatment with systemic anti-cancer therapies within 3 weeks before study treatment
- Radiotherapy within 4 weeks or limited palliative radiation within 2 weeks prior to study treatment
- Unable to provide informed consent
- Prior stem cell or bone marrow transplant
- Abnormal cachexia
- Distended abdomen from ascites
- Participation in other investigational treatment studies within 4 weeks before study treatment start date in this study
- Patient withdrawal or intolerance criteria met during the study treatment period as reasons for discontinuation are also considered exclusion factors for ongoing treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until disease progression, intolerable toxicity, or withdrawal of consent
Participants receive PRL3-zumab every 2 weeks until disease progression, intolerable toxicity, or withdrawal of consent. The treatment involves repeated cycles of two infusions over 4 weeks per cycle.
Biweekly visits for infusions, with assessments every 8 weeks
Follow-up
Duration - Up to 6 months after last dose
After treatment ends, participants have an end-of-treatment visit within 14 days and a safety follow-up visit 28 days after the last dose. Monthly survival follow-up calls continue for 6 months after the safety follow-up visit.
1 end-of-treatment visit, 1 safety follow-up visit, and monthly follow-up calls for 6 months
Trial Site Locations
Total: 4 locations
1
Hosp. Universiti Sains Malaysia (HUSM), Kelantan
Kota Bharu, Malaysia
Actively Recruiting
2
Beacon Hospital
Kuala Lumpur, Malaysia
Actively Recruiting
3
Hosp. Kuala Lumpur
Kuala Lumpur, Malaysia
Actively Recruiting
4
University Malaysia Medical Centre
Kuala Lumpur, Malaysia
Actively Recruiting
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Research Team
M
Ms Munirah Jamaluddin
D
Dr Min Thura
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Exploiting frequent and specific expression of PRL3 in pediatric solid tumors for first-in-child use of PRL3-zumab humanized antibody.
Amos Hong Pheng Loh, Min Thura, Abhishek Gupta...
https://pubmed.ncbi.nlm.nih.gov/37674627A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies.
Cheng E Chee, Melissa Ooi, Soo-Chin Lee...
https://pubmed.ncbi.nlm.nih.gov/37060431PRL3 induces polypoid giant cancer cells eliminated by PRL3-zumab to reduce tumor relapse.
Min Thura, Zu Ye, Abdul Qader Al-Aidaroos...
https://pubmed.ncbi.nlm.nih.gov/34326464PRL3-zumab as an immunotherapy to inhibit tumors expressing PRL3 oncoprotein.
Min Thura, Abdul Qader Al-Aidaroos, Abhishek Gupta...
https://pubmed.ncbi.nlm.nih.gov/31171773PRL3-zumab, a first-in-class humanized antibody for cancer therapy.
Min Thura, Abdul Qader Omer Al-Aidaroos, Wei Peng Yong...
https://pubmed.ncbi.nlm.nih.gov/27699276Targeting intracellular oncoproteins with antibody therapy or vaccination.
Ke Guo, Jie Li, Jing Ping Tang...
https://pubmed.ncbi.nlm.nih.gov/21900592