PRL3-zumab for Solid Tumors

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

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests PRL3-zumab, a medicine given alone through an IV, in patients with tumors that can't be removed by surgery or have spread. The treatment involves regular infusions to help manage the cancer.

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.

What evidence supports the effectiveness of the treatment PRL3-zumab for solid tumors?

The research on antibody-drug conjugates (ADCs) shows that these treatments can effectively target cancer cells by combining antibodies with toxic agents, leading to fewer side effects compared to traditional chemotherapy. This approach has been successful in other cancers, suggesting potential for PRL3-zumab in treating solid tumors. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Arming antibodies: prospects and challenges for immunoconjugates. [2019]

2. United States 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. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Co-Targeting HER3 and EpCAM Using Seribantumab and DARPin-Toxin Fusion in a Pancreatic Cancer Xenograft Model. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Preclinical Efficacy of Anti-RON Antibody-Drug Conjugate Zt/g4-MMAE for Targeted Therapy of Pancreatic Cancer Overexpressing RON Receptor Tyrosine Kinase. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Antibody-Drug Conjugates for the Treatment of Solid Tumors: Clinical Experience and Latest Developments. [2020]