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RECRUITING 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

NCT07213817 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 114 participants
Start Date 2025-12-05
Est. Completion 2028-10-30
Phase Phase 1

Sponsor

Ipsen

205 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07213817 reports 12 study locations spanning 6 distinct geographic areas — top geographies include Other, Texas, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07213817?

The interventions under investigation include: IPN60300 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07213817?

This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial