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NCT07213817 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours
A Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Ipsen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
- 12
- Study locations
NCT07213817 is a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor that is actively recruiting participants, run by Ipsen. The registered enrollment target is 114 participants, below the 190-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (40% lower). The trial reports 12 study locations across 6 states.
The verdict
NCT07213817, a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, is actively recruiting participants, sponsored by Ipsen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
- 12
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL IPN60300
Study Locations (12)
Other
- Centre Leon Berard - Lyon
- Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau - Saint-Herblain
- Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) - Villejuif
- Hospital Universitari Vall d'Hebron - Barcelona
- NEXT Quiron-Barcelona - Barcelona
- START Madrid CIOCC Hospital Universitario HM Sanchinarro - Madrid
Texas
- MD Anderson Cancer Center - Houston
- NEXT Oncology - San Antonio
Connecticut
- Yale Cancer Center-Yale University - New Haven
Michigan
- START Midwest - Grand Rapids
Pennsylvania
- Sidney Kimmel Cancer Center - Philadelphia
Virginia
- NEXT Oncology - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2025-12-05 |
| Est. Completion | 2028-10-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07213817
The ClinicalTrials.gov registry entry for NCT07213817 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (40% lower). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which IPN60300 is the first listed.
NCT07213817 reports 12 study locations spanning 6 distinct geographic areas - top geographies include Other, Texas, Connecticut.
Frequently Asked Questions
What is clinical trial NCT07213817 about?
NCT07213817 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours". 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 Phase...
What is the current status of trial NCT07213817?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2025-12-05. Estimated completion is 2028-10-30.
What conditions does trial NCT07213817 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor.
What interventions are being tested in trial NCT07213817?
The interventions under investigation include: IPN60300 (BIOLOGICAL).
Who is sponsoring clinical trial NCT07213817?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07213817 being conducted?
This trial has 12 study locations across Connecticut, Michigan, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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