Study on the Safety and Effectiveness of IPN60300 in Adults with Advanced Solid Tumors

Sponsor: Ipsen

Sponsor score: 0

ClinicalTrials ID:NCT07213817

This clinical trial is testing a new drug, IPN60300, to find the right dose and evaluate its safety and effectiveness in adults with advanced solid tumors. Participants will receive the drug through injections.

Patient Parameters

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Program Overview

The purpose of this study is to determine the best dose and assess the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumors, which are cancers that have spread from their original location. Participants will receive the drug by injection. The study is divided into two phases: Phase Ia, where participants with certain tumor types will receive increasing doses to find a safe and effective range, and Phase Ib, where participants with a specific tumor type will receive one of the doses identified in Phase Ia. The study includes a screening period of up to 28 days to determine eligibility, followed by a treatment period that continues until the drug needs to be stopped for various reasons, such as side effects or disease progression. Participants will undergo various tests and evaluations throughout the study.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have advanced solid tumors that have returned or not responded to previous treatments, or for which no standard treatment is available or appropriate.
Have measurable disease according to specific medical criteria.
Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Use contraception as required by local regulations.
Have adequate bone marrow, kidney, and liver function as determined by specific tests.
Provide a tumor tissue sample for study purposes.
Be able to give informed consent and comply with study requirements.
Have a life expectancy of more than 3 months.

Exclusion Criteria

Have another progressing or actively treated cancer within the last 2 years.
Have significant side effects from previous cancer treatments.
Have had major surgery within the last 4 weeks.
Have had a solid organ transplant.
Have severe eye disorders or a history of corneal transplant.
Have active or untreated brain metastases, except for stable, treated cases.
Have had a stroke or significant heart or lung disease within the last 6 months.
Have significant gastrointestinal disorders or severe infections.
Have uncontrolled medical conditions that pose a risk for study participation.
Have uncontrolled HIV or active hepatitis B or C infections.
Be on ongoing immunosuppressive therapy.
Be participating in another treatment trial.
Be institutionalized or under legal protection (specific to French participants).

Locations

FACILITY	ZIP	CITY	STATE
START Midwest	49546	Grand Rapids	Michigan

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