IPN01195 for Cancer

Recruiting at 13 trial locations

Overseen By Ipsen Clinical Study Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ipsen

Must not be taking: Corticosteroids, Immunosuppressives, others

Disqualifiers: Infections, Cardiac issues, Brain metastases, others

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

Compensation: Varies

Number of Visits: 11

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, IPN01195, as a potential cancer treatment to determine the appropriate dose and assess its safety and effectiveness for adults with advanced solid tumors. These tumors have spread to nearby tissues or other body parts. Participants should have a solid tumor with specific genetic changes and no other standard treatment options available. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 28 days for any prior anti-cancer therapy, including chemotherapy, targeted agents, and radiotherapy. If you are on a medication with a short half-life, the washout can be shorter but not less than 5 times the half-life. Additionally, you cannot be on systemic corticosteroids or other immunosuppressive medications within 2 weeks before starting the study.

Is there any evidence suggesting that IPN01195 is likely to be safe for humans?

Research shows that IPN01195 is in the early stages of testing to assess its safety and tolerability. These are the first studies involving humans, so information remains limited. However, reaching this stage indicates that scientists have conducted lab or animal tests and found it promising enough for human trials.

Researchers are examining how the drug behaves in the body and monitoring for side effects. Since it's early in development, complete safety details are not yet available. This phase focuses on identifying safe dosage levels and observing any reactions. Moving to human trials is a positive step, and participants are closely monitored to ensure their safety as more information is gathered. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about IPN01195 because it offers a novel approach to treating cancer. Unlike standard treatments like chemotherapy and radiation, which often attack both healthy and cancerous cells, IPN01195 is designed to target cancer cells more precisely, potentially reducing side effects and improving patient outcomes. Additionally, its mechanism of action may enable it to work in cases where other treatments have failed, providing new hope for those with resistant forms of cancer. This targeted approach could revolutionize how we manage and treat cancer, making it a promising option in the field of oncology.

What evidence suggests that IPN01195 might be an effective treatment for advanced solid tumours?

Research has shown that IPN01195 is under investigation as a potential treatment for advanced solid tumors. This trial involves two parts: Part A focuses on dose escalation to determine the appropriate dose level, and Part B randomizes participants to one of two doses of interest once the PADR is determined. Although the effectiveness in people is still under study, early research aims to find the right dose and understand how the drug functions in the body. The drug targets specific pathways that aid tumor growth, potentially slowing or stopping cancer spread. Initial results suggest it could provide a new treatment option for cancers that have metastasized. However, more information is needed to fully understand its effects on patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, which means cancers in organs or tissues that have spread. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them.

Inclusion Criteria

Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1

I am fully active or restricted in physically strenuous activity but can do light work.

I am at least 18 years old or the legal adult age in my country.

Exclusion Criteria

I am not currently receiving any other cancer treatments.

Underlying medical conditions that may obscure toxicity determination or adverse events interpretation

Current or recent participation in other clinical studies involving investigational treatments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I Part A (Dose Escalation)

Participants receive escalating doses of IPN01195 to determine the dose range showing activity on the tumour that can be tolerated

Up to 24 weeks

At least 2 visits in the first month, then monthly visits

Treatment Phase I Part B (Dose Confirmation)

Participants receive either a low or high dose of IPN01195 to assess tumour response and safety

Up to 24 weeks

At least 2 visits in the first month, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit at 30 days after last administration

Phase II Extension

Further evaluation of the study drug based on results from Phase I

Up to 3 years

Assessment every 6 weeks up to Week 24, then every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IPN01195

Trial Overview The study is testing IPN01195 to find the right dose and see how safe and effective it is for treating advanced solid tumors. Participants will receive this new medication to evaluate its impact on their cancer.

How Is the Trial Designed?

Group I: Part B - (randomisation) Experimental Treatment 1 Intervention

Participants will be randomised to one of the two doses of interest once the PADR is determined

Group II: Part A (dose escalation) Experimental Treatment 1 Intervention

IPN01195 will be administered at assigned dose level.

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06833008

A Study to Assess a New Medicine Called IPN01195 When ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/577618

A Study to Assess a New Medicine Called IPN01195 When ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06833008/a-study-to-assess-a-new-medicine-called-ipn01195-when-administered-alone-in-adults-with-advanced-solid-tumours

A Study to Assess a New Medicine Called IPN01195 When ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with ...

4. withpower.com withpower.com/trial/phase-2-solid-tumors-advanced-solid-tumors-1-2025-4ab8a

IPN01195 for Cancer · Recruiting Participants for Phase ... The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.

5. synapse.patsnap.com synapse.patsnap.com/drug/dea500f1d4aa488ea1109cc0784e88b4

IPN-01195 - Drug Targets, Indications, Patents An open-label, Phase I/II first-in-human, dose escalation and confirmation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-ipn01195-in-adults-with-advanced-solid-tumors/

Study on the Safety and Effects of IPN01195 in Adults ... This clinical trial is examining the safety and effectiveness of the drug IPN01195 as a potential treatment for adults with advanced solid tumors.

7. ipsen.com ipsen.com/update/esmo-2025-new-data-reinforces-breadth-and-depth-of-ipsens-growing-oncology-pipeline-and-portfolio-3165272/

ESMO 2025: new data reinforces breadth and depth of ... In 2025, IPN01195 progressed to Phase I/II first in human studies to assess the safety, tolerability, pharmacokinetic, pharmacodynamic and ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)02515-3/abstract

1026eTiP Phase I/II first-in-human (FIH) study to assess the ... Nonclinical assessment of IPN01195 showed strong in vitro potency in a panel of MAPKm cancer cell lines, and robust and sustained antitumour activity in a panel ...