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Study of IPN01203 for Advanced Solid Tumors

This study is testing a new drug called IPN01203 in adults with advanced solid tumors (cancers that have spread). The main goals are to find the right dose, check its safety, and see how well it works against the cancer. You might be able to join if you are at least 18 years old, have a good general health status (ECOG 0-1), and your cancer can be measured. The study will look at how many participants experience side effects and how many see their tumors shrink or stop growing. This drug works by targeting a mechanism called a checkpoint inhibitor.

Study design
This is an interventional study with a planned enrollment of 102 participants. It has two parts: an initial phase (Phase Ia) to find the best dose, and a second phase (Phase Ib) to further assess the drug's effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects from the first dose until 90 days after their last dose. The study will assess tumor response up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07213830

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ipsen
~102 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:IPN01203

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with dose limiting toxicity (DLT)
Measured over Within 28 days of first dose
+2 more outcomes measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor

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Solid Neoplasm

NCT07213830

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Villejuif, Franceno site contact published

    Recruiting

  • Hospital Fundacion Jimenez Diaz

    Madrid, Spainno site contact published

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spainno site contact published

    Recruiting

  • NEXT Quiron-Barcelona

    Barcelona, Spainno site contact published

    Recruiting

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennesseeno site contact published

    Recruiting

  • South Texas Accelerated Research Therapeutics (START) - Midwest

    Grand Rapids, Michiganno site contact published

    Recruiting

  • South Texas Accelerated Research Therapeutics (START) - San Antonio

    San Antonio, Texasno site contact published

    Recruiting

  • START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)

    Madrid, Spainno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Clinical Study Enquiries
[email protected]
See email
Email the study team

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Eligibility criteria

Inclusion

Participant must be ≥18 years of age, at the time of signing the informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and/or MRI.
All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.
Have a life expectancy for disease-related mortality, as evaluated by the investigator.
Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Adequate haematologic and end organ function
Participant is capable of giving signed informed consent as described in the protocol.

Exclusion

Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.
Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
History of known autoimmune disease
History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.
History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
Prior organ transplantation.
Chronic or ongoing active infections within 4 weeks prior to Cycle1 Day1 (C1D1).
Presence of hepatitis B surface antigen (HBsAg) \[or hepatitis B core antibody (HBcAb)\] at screening or within 3 months prior to the first dose of study intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.
Participants with known history of HIV infection are excluded from the study unless they meet the following criteria:
History of other malignancy within the last years.
Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures per investigator including, but not limited to renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
Treatment with \>10 mg per day of prednisone (or equivalent) or other immune suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for participants who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
Concurrent participation in another therapeutic treatment study.
Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.
For French participants only: participants are under court protection, not affiliated to a social security system or protected adults.

What this trial measures

  • Percentage of participants with dose limiting toxicity (DLT)Within 28 days of first dose
  • Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs).From the first IPN01203 administration to 90 days after the last dose.

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began

  • Phase Ib: Objective Response Rate (ORR)At end of study (up to approximately 3 years)

    Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1.