RecruitingPhase 1Phase 2NCT07213817

A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours

An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumours.


Sponsor

Ipsen

Enrollment

114 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection. Study Phases: * 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 (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance). Study Periods: Screening: Up to 28 days before first IPN60300 injection to determine eligibility. Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor. Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called IPN60300 for people with locally advanced solid tumor and metastatic solid tumor. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIPN60300

IPN60300 will be administered at assigned dose level.


Locations(12)

Yale Cancer Center-Yale University

New Haven, Connecticut, United States

START Midwest

Grand Rapids, Michigan, United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

Centre Leon Berard

Lyon, France

Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau

Saint-Herblain, France

Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)

Villejuif, France

Hospital Universitari Vall d'Hebron

Barcelona, Spain

NEXT Quiron-Barcelona

Barcelona, Spain

START Madrid CIOCC Hospital Universitario HM Sanchinarro

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07213817


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