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NCT07213830 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies

A Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Ipsen.

Recruiting
Registry status
Phase 1
Development phase
102
Enrollment target
10
Study locations

NCT07213830 is a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor that is actively recruiting participants, run by Ipsen. The registered enrollment target is 102 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (47% lower). The trial reports 10 study locations across 5 states.

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The verdict

NCT07213830, a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, is actively recruiting participants, sponsored by Ipsen.

RECRUITING
Registry status
Phase 1
Development phase
102 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body. There will be two parts to this study: * Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. * Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability. An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib. Each part will consist of the following periods: * A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first. There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier. In both parts of the study, participants will undergo blood sampling, urine collection, physical exa

Conditions Studied

Advanced Solid Tumor Metastatic Solid Tumor

Interventions

  • BIOLOGICAL IPN01203

Study Locations (10)

Other

  • Princess Margaret Cancer Center PI Spreafico - Toronto
  • Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) - PI Ronan - Villejuif
  • Hospital Universitario Vall d'Hebron PI Garralda Cabanas - Barcelona
  • NEXT Quiron-Barcelona - PI Saavedra Santa Gadea - Barcelona
  • START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC) - Calvo Aller - Madrid

Texas

  • MD Anderson PI Champiat - Houston
  • Start San Antonio PI Rasco - San Antonio

Michigan

  • START MidWest PI Sharma - Grand Rapids

Tennessee

  • Sarah Cannon Research Institute PI McKean Nasville, TN, USA - Nashville

Virginia

  • NEXT PI Spira - Fairfax

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2026-02-06
Est. Completion 2032-07-14
Phase Phase 1

Sponsor

Ipsen

85 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07213830

The ClinicalTrials.gov registry entry for NCT07213830 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (47% lower). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which IPN01203 is the first listed.

NCT07213830 reports 10 study locations spanning 5 distinct geographic areas - top geographies include Other, Texas, Michigan.

Frequently Asked Questions

What is clinical trial NCT07213830 about?

NCT07213830 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies". The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or oth...

What is the current status of trial NCT07213830?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2026-02-06. Estimated completion is 2032-07-14.

What conditions does trial NCT07213830 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Metastatic Solid Tumor.

What interventions are being tested in trial NCT07213830?

The interventions under investigation include: IPN01203 (BIOLOGICAL).

Who is sponsoring clinical trial NCT07213830?

This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07213830 being conducted?

This trial has 10 study locations across Michigan, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.