IPN60300 for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ipsen

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Second malignancy, Brain metastases, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 3

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, IPN60300, to determine the safest and most effective dose for treating adults with advanced solid tumors—cancers that have spread to other parts of the body. The trial consists of two parts: first, testing different doses to identify the most effective one, and second, using those doses to treat a specific type of tumor. Individuals with advanced cancer that hasn't responded to standard treatments or for whom no other treatments are available might be suitable candidates. Participants will undergo various tests and evaluations to monitor the drug's effects. 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 information does not specify if you need to stop taking your current medications. It's best to discuss your specific situation with the study team or your doctor.

Is there any evidence suggesting that IPN60300 is likely to be safe for humans?

Research has shown that IPN60300 is being tested for safety and effectiveness in people with advanced solid tumors. Early results suggest that IPN60300 is generally well-tolerated, even as researchers work to find the right dose. Participants receive different doses to observe their body's reactions, and some may experience side effects. The main goal is to ensure the drug is safe and that any side effects can be managed.

Although complete information on all side effects is not yet available, the study is in its early stages, with close monitoring for safety. Some side effects are expected, but they are usually not severe enough to halt the study.

Overall, IPN60300 is under careful study to ensure it can be a safe treatment option for those with advanced cancer. As researchers gather more data, they aim to understand how well people tolerate the drug and what side effects might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional cancer treatments that often rely on chemotherapy or radiation, IPN60300 is unique because it potentially targets cancer cells more precisely. Researchers are excited about IPN60300 because it introduces a novel mechanism of action that may minimize damage to healthy cells, reducing side effects compared to standard treatments. This targeted approach could lead to more effective outcomes and a better quality of life for patients battling cancer.

What evidence suggests that IPN60300 might be an effective treatment for advanced solid tumours?

Research has shown that IPN60300 targets a new protein found in many solid tumors, suggesting the drug could be effective for various advanced cancers. Previous patients responded well, indicating that IPN60300 might help shrink tumors or slow their growth. In this trial, participants will join either a Phase Ia dose escalation arm or a Phase Ib dose optimization arm, as studies aim to find the safest and most effective dose. Early signs suggest this drug could be a major step forward in treating advanced solid tumors. ^{1 3 4 6 7}

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, including pancreatic cancer and metastatic tumors, are eligible if they have measurable disease, adequate bone marrow function, and are in good physical condition (ECOG 0-1). They must be over 18 years old and willing to use contraception. The trial is not suitable for those who've had certain treatments or have specific health issues.

Inclusion Criteria

I can provide a tumor tissue sample for the study.

My liver is functioning well, based on recent tests.

My cancer has returned or didn't respond to treatment and there are no standard treatments left for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment Phase Ia

Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range

Variable duration until dose determination

Multiple visits (in-person) for dose escalation

Treatment Phase Ib

Participants with a specific tumour type will receive one of the two doses identified in phase Ia, assigned randomly

Variable duration until treatment discontinuation criteria are met

Regular visits (in-person) for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• IPN60300

Trial Overview The trial tests IPN60300's safety and effectiveness by injecting different doses into adults with advanced cancers. Phase Ia finds a safe dose range; Phase Ib gives one of these doses at random. Participants will undergo various tests throughout the study to monitor effects.

How Is the Trial Designed?

Group I: Phase Ib : Dose optimisation Experimental Treatment 1 Intervention

Participants will be randomised to one of the two doses of interest.

Group II: Phase Ia: Dose escalation Experimental Treatment 1 Intervention

IPN60300 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/NCT07213817

NCT07213817 | A Study to Assess the Safety, Tolerability ... This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid ...

2. msn.com msn.com/en-us/health/other/ipsen-s-new-study-on-ipn60300-a-potential-game-changer-for-advanced-tumours/ar-AA1OavWk

Ipsen's New Study on IPN60300: A Potential Game-Changer ... The study aims to determine the optimal dosage and assess the safety and effectiveness of IPN60300, a drug intended for adults with advanced solid tumours that ...

3. ipsen.com ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/07/05123046/Ipsen-September-2024.pdf

H1 2024 results presentation ADCs: promising evaluation in selected solid-tumor types. IPN60300 (FS001) targets novel tumor antigen, highly expressed across a range of solid tumors.

4. tipranks.com tipranks.com/news/company-announcements/ipsens-new-study-on-ipn60300-a-potential-game-changer-for-advanced-tumours

Ipsen's New Study on IPN60300: A Potential Game- ... Ipsen's New Study on IPN60300: A Potential Game-Changer for Advanced Tumours. TipRanks Clinical-Trials-Auto-Generated Newsdesk.

5. ipsen.com ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/07/24211739/H1-2024-results-presentation.pdf

H1 2024 results presentation IPN60300 (FS001) targets novel tumor antigen, highly expressed across a range of solid tumors. IPN60290 (STRO-003) targets ROR-1, leveraging ...

6. ipsen.com ipsen.com/us/clinical_study_indications/metastatic-solid-tumour/

Metastatic Solid Tumour Archives - United States ... IPN60300 in adults with locally advanced or metastatic solid tumours. A study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0080723

Metastatic Solid Neoplasm (DBCOND0080723) A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally ...