IPN01203 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, IPN01203, for individuals with advanced solid tumors, which are cancers that have spread beyond their original site. The trial aims to determine the optimal dose that is both safe and effective in combating these tumors. It consists of two parts: the first part evaluates different doses to identify the most effective one, while the second part assesses how well the chosen doses work and how the body processes the drug. Individuals with cancers that have spread to other parts of the body might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it mentions that some medications can be continued if details are recorded. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that IPN01203 is likely to be safe for humans?
Research shows that IPN01203 is being tested to determine the right dose and ensure its safety for people with advanced solid tumors. Early studies have focused on the drug's tolerability, assessing whether side effects are manageable.
These studies have tested different doses to find the most effective one against tumors with minimal side effects. The goal is to identify a dose that is both effective and safe for patients. Although these studies are ongoing, the treatment has demonstrated some level of safety, allowing further testing.
It's important to remember that while the drug is under study for safety, it remains in the trial phase. Researchers are still learning about its effects and side effects. Participants in the trial will be closely monitored to ensure their safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about IPN01203 because it represents a novel approach to cancer treatment. Unlike many current cancer therapies that target rapidly dividing cells in general, IPN01203 is designed to specifically target cancer cells with precision, potentially minimizing damage to healthy cells. This targeted mechanism may result in fewer side effects compared to traditional chemotherapy. Additionally, IPN01203 is administered intravenously, allowing direct delivery of the treatment into the bloodstream, potentially enhancing its efficacy.
What evidence suggests that IPN01203 might be an effective treatment for advanced solid tumours?
Research has shown that IPN01203 is being developed to treat advanced solid tumors, which are cancers that have spread from their original location. Early findings suggest that IPN01203 targets and disrupts cancer cells, potentially slowing or stopping tumor growth. Studies have demonstrated the drug's anti-tumor activity in early tests on models before human trials. Although information from human trials remains limited, these early results offer hope that IPN01203 might effectively treat these cancers. Participants in this trial will receive IPN01203 in either a dose escalation phase or a dose optimization phase to determine the most effective dosing strategy.13467
Who Is on the Research Team?
Ipsen Medical Director
Principal Investigator
Ipsen
Are You a Good Fit for This Trial?
Adults with advanced solid tumors who have previously been treated with immune checkpoint inhibitors can join. They must be over 18, able to consent, and in good enough health (ECOG status of 0-1). Prior treatment side effects should be mild except for certain chronic issues like mild neuropathy or hair loss. Participants need a measurable tumor and adequate organ function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IPN01203 with dose escalation in Phase Ia and dose optimisation in Phase Ib
End of Treatment
One visit 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment
Follow-up
Safety follow-up visit 90 days after the last administration of study intervention or prior to the start of new anticancer treatment
What Are the Treatments Tested in This Trial?
Interventions
- IPN01203
Trial Overview
The trial is testing IPN01203's safety and effectiveness on advanced solid tumors. It has two phases: Phase Ia finds the right dose range; Phase Ib optimizes dosage based on tumor response and drug processing by the body. A possible phase II will depend on these results.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will randomly receive one of the two doses of interest, determined at the end of Phase Ia, of IPN01203 administered intravenously (IV).
Participants will receive assigned dose level IPN01203 administered intravenously (IV).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ipsen
Lead Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD
Citations
NCT07213830 | A Study to Assess the Safety, Tolerability ...
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Find a clinical trial | Ipsen Global
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
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ipsen.com
ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/07/05123046/Ipsen-September-2024.pdfH1 2024 results presentation
Disclaimer: trials are event-driven & timings can change. Oncology. Rare Disease. Neuroscience. Information shown as at end of June 2024. Phase I.
Metastatic Solid Neoplasm (DBCOND0080723)
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally ...
BOOST:Better Oncology Outcomes Through Statin Treatment
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6.
ipsen.com
ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/07/24211739/H1-2024-results-presentation.pdfH1 2024 results presentation
This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and ...
IPN60300 for Cancer · Recruiting Participants for Phase ...
Research has shown that IPN60300 is being tested for safety and effectiveness in people with advanced solid tumors. Early results suggest ...
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