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A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours
Sponsor: Ipsen
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2025-12-05
Completion Date
2028-10-30
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
IPN60300
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