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

Trial Summary

What is the purpose of this trial?

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. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.

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.

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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