Authorised Phase I and Phase II (Integrated)- First administration to humans Advanced Solid Tumor, Metastatic Solid Tumor

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

EU CTIS ID: 2025-522184-15-00

What this study is testing

Phase Ia To evaluate the safety and tolerability of IPN01203 as a single agent and determine the MTD/MAD in participants with selected tumours Phase Ib To determine the optimal dosing regimen of IPN01203 in selected tumours

Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Participant must be ≥18 years of age, at the time of signing the informed consent.
2. ECOG performance status of 0 to 1
3. 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.
4. 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 that are stable of moderate intensity (Grade ≤2) and well controlled can be included
5. Have a life expectancy for disease-related mortality, as evaluated by the investigator.
6. 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.

You likely can't join if

1. Have untreated or active primary brain tumour, CNS metastases, leptomeningeal disease, or spinal cord compression.
18. For French participants ONLY: participants are under court protection, not affiliated to a social security system or protected adults.
2. Experienced severe, life-threatening immune-mediated AEs, or infusionrelated reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
4. History of known autoimmune disease
5. 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.
6. History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional exclusion criteria include: a. Left ventricular ejection fraction <45% b. QT interval corrected by Fridericia (QTcF) >470 ms (for women) and >450 ms (for men) or CS arrhythmias.

See the full eligibility criteria

Who can join

1. Participant must be ≥18 years of age, at the time of signing the informed consent.
2. ECOG performance status of 0 to 1
3. 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.
4. 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 that are stable of moderate intensity (Grade ≤2) and well controlled can be included
5. Have a life expectancy for disease-related mortality, as evaluated by the investigator.
6. 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.
7. Adequate haematologic and end organ function
8. Participant is capable of giving signed informed consent as described in the protocol.

What rules you out

1. Have untreated or active primary brain tumour, CNS metastases, leptomeningeal disease, or spinal cord compression.
18. For French participants ONLY: participants are under court protection, not affiliated to a social security system or protected adults.
2. Experienced severe, life-threatening immune-mediated AEs, or infusionrelated reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
4. History of known autoimmune disease
5. 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.
6. History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional exclusion criteria include: a. Left ventricular ejection fraction <45% b. QT interval corrected by Fridericia (QTcF) >470 ms (for women) and >450 ms (for men) or CS arrhythmias.
7. History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
8. Prior organ transplantation.
9. Chronic or ongoing active infections within 4 weeks prior to C1D1.
10. 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.
11. Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.
12. Participants with known history of HIV infection are excluded from the study unless they meet the following criteria: a. Stable Antiretroviral Therapy: Participants must be on a stable antiretroviral therapy regimen for at least 4 weeks prior to enrolment. b. CD4+ T cell Count: Participants must have a CD4+ T cell count of at least 200 cells/µL. c. Viral Load: Participants must have an undetectable viral load (HIV RNA <50 copies/mL) d. No Opportunistic Infections: Participants must not have had any opportunistic infections or other human immunodeficiency virus (HIV)-related illness within the past 6 months Note: HIV testing will be performed in any countries where it is mandatory per local requirements.
13. History of other malignancy within the last years.
14. 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.
15. 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 allergicreaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
16. Concurrent participation in another therapeutic treatment study.
17. Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.