PRL3-zumab for Solid Tumors

Not currently recruiting at 4 trial locations

Overseen By Rio Aquino

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Intra-IMMUSG Pte Ltd

Must not be taking: Glucocorticoids, Immunosuppressives

Disqualifiers: CNS metastasis, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests PRL3-zumab, an experimental drug for patients with hard-to-remove or spreading solid tumors. Researchers aim to evaluate the drug's effectiveness and safety for individuals whose cancer hasn't responded to other treatments. Suitable candidates have solid tumors that can't be surgically removed or have spread, and they have already tried up to three different treatments. Participants must also have a life expectancy of more than six months. This trial offers a new approach to managing cancer. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of potentially effective cancer therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic glucocorticoids or other immunosuppressive treatments. Also, you must not have had any systemic anti-cancer therapies within 3 weeks before starting the study treatment.

Is there any evidence suggesting that PRL3-zumab is likely to be safe for humans?

Research has shown that PRL3-zumab is safe for humans. Studies have found that individuals with solid tumors and blood cancers tolerate it well. In an earlier study, patients with advanced cancer experienced no major safety problems with PRL3-zumab.

Reports from these studies noted no serious safety issues, suggesting that the treatment is generally safe for people with advanced solid tumors. For those considering joining a trial with PRL3-zumab, current evidence supports its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PRL3-zumab is unique because it targets PRL-3, a protein often linked to cancer progression, which distinguishes it from traditional chemotherapy and immunotherapy options for solid tumors. Unlike standard treatments that might broadly attack cancer cells, PRL3-zumab specifically aims at interrupting the pathways that enable tumor growth and spread. Researchers are excited about this treatment because it offers a more targeted approach, potentially leading to fewer side effects and better outcomes for patients with solid tumors.

What evidence suggests that PRL3-zumab might be an effective treatment for solid tumors?

Research has shown that PRL3-zumab, the treatment under study in this trial, may help treat solid tumors. In earlier studies, patients with advanced cancer generally tolerated PRL3-zumab well, indicating it is usually safe. One study found that the treatment helped stop cancer progression in about 12% of patients. These results suggest that PRL3-zumab might benefit people with hard-to-treat cancers. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with solid tumors that can't be surgically removed or have spread, who've had at least one but no more than three treatments for metastatic disease. They should be relatively active (ECOG score ≤2), expect to live more than six months, and not currently on immunosuppressants or have had recent cancer treatment.

Inclusion Criteria

Patients with unresectable or metastatic solid tumors willing to provide signed informed consent

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

Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than 2

Exclusion Criteria

You have had a very bad allergic reaction to another type of medication called monoclonal antibody.

Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition

Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive PRL3-zumab monotherapy administered by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity

Up to 6 months

Visits every 2 weeks (in-person)

End of Treatment

End of Treatment visit occurs within 14 days of the decision to discontinue treatment for any reason

2 weeks

1 visit (in-person)

Follow-up

Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PRL3-zumab

Trial Overview The study tests PRL3-zumab as a single therapy in people with advanced solid tumors. It's an open-label Phase 2 trial, meaning both researchers and participants know what treatment is being given, and it involves just one dose level of the drug.

How Is the Trial Designed?

Group I: PRL3-zumab Experimental Treatment 1 Intervention

All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.

Who Is Running the Clinical Trial?

Intra-IMMUSG Pte Ltd

Lead Sponsor

Trials

1

Recruited

50+

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

KTN3379, a fully human monoclonal antibody targeting HER3, effectively suppresses HER3 activity and inhibits tumor growth in various cancer models, regardless of whether HER3 activation is ligand-dependent or independent.

The study found that loss of the PTEN gene, which is common in many cancers, reduces the effectiveness of KTN3379 in HER2-amplified tumors, suggesting that patient selection for this treatment may need to consider PTEN status to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Potent HER3 Monoclonal Antibody That Blocks Both Ligand-Dependent and -Independent Activities: Differential Impacts of PTEN Status on Tumor Response. Xiao, Z., Carrasco, RA., Schifferli, K., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666379125001934

A multicenter, single-dose-level phase 2 basket clinical trial ... PRL3-zumab demonstrates excellent safety and clear clinical benefits in late-stage IV solid cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10192144/

A Phase I, First-in-Human Study of PRL3-zumab ... In conclusion, this first-in-human study has demonstrated that PRL3-zumab, a humanized mAb against PRL3, is safe and tolerable in advanced solid ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04118114

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors This is a Phase II, open-label, single dose level study of PRL3-ZUMAB monotherapy in patients with advanced solid tumours that have failed standard therapy.

4. cell.com cell.com/cell-reports-medicine/pdf/S2666-3791(25)00193-4.pdf

The PRL3-zumab paradigm: A multicenter, single- dose- ... PRL3-zumab showed its excellent drug safety profile in the first-in-man phase 1 trial with 27 end-stage cancer patients (23 solid tumors and 4 ...

5. asianscientist.com asianscientist.com/2023/07/in-the-lab/this-new-antibody-drug-shows-promising-results-against-cancer/

This New Antibody Drug Could Slow Down Cancer The study also evaluated 24 patients for treatment efficacy and found that PRL3-zumab stabilized cancer progression in one-eighth of patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04452955

A Study to Assess Safety and Efficacy of PRL3-Zumab in ... To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors. From first dose of study drug until disease progression or end of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37060431/

A Phase I, First-in-Human Study of PRL3-zumab ... PRL3-zumab, a first-in-class humanized antibody, was safe and tolerable in solid tumors and hematological malignancies.