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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ipsen Pharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Feb 2026 → ongoing

Decision date (initial)

2025-12-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ipsen Pharma SAS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Pharmacokinetic, Therapy, Pharmacodynamic, Efficacy

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

Secondary objectives 5

1. Phase Ia 1. To characterise single and multiple doses PK of IPN01203
2. 2. To assess the immunogenicity potential of IPN01203
3. 3. To assess the preliminary clinical benefit of IPN01203 by evaluation of anti-tumour activity
4. Phase Ib 4. To assess clinical activity of IPN01203 as a single agent in participants with selected advanced or metastatic solid tumours
5. 5. To further assess the immunogenicity potential of IPN01203

Conditions and MedDRA coding

Advanced Solid Tumor, Metastatic Solid Tumor

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Participant must be ≥18 years of age, at the time of signing the informed consent.
2. 2. ECOG performance status of 0 to 1
3. 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. 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. 5. Have a life expectancy for disease-related mortality, as evaluated by the investigator.
6. 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. 7. Adequate haematologic and end organ function
8. 8. Participant is capable of giving signed informed consent as described in the protocol.

Exclusion criteria 17

1. 1. Have untreated or active primary brain tumour, CNS metastases, leptomeningeal disease, or spinal cord compression.
2. 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.
3. 11. Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.
4. 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.
5. 13. History of other malignancy within the last years.
6. 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.
7. 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.
8. 16. Concurrent participation in another therapeutic treatment study.
9. 17. Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.
10. 18. For French participants ONLY: participants are under court protection, not affiliated to a social security system or protected adults.
11. 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.
12. 4. History of known autoimmune disease
13. 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.
14. 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.
15. 7. History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
16. 8. Prior organ transplantation.
17. 9. Chronic or ongoing active infections within 4 weeks prior to C1D1.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT)
2. 2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs)
3. Ph Ib 3. objective response rate (ORR) 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

Secondary endpoints 11

1. Ph Ia 1.Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203
2. 2. Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203
3. 3. Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203
4. 4. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies
5. 5. Objective response rate (ORR)
6. 6. Ph Ib Duration of response (DoR). DoR is defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first
7. 7. Duration of stable disease (SD). SD is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first, for participants with SD as best response, with a minimum SD duration of 8 weeks
8. 8. Progression-free survival (PFS). PFS is defined as the time from the date of first IPN01203 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first.
9. 9. Disease control rate (DCR). DCR is defined as the percentage of participants with BOR of CR, PR, or SD, as determined by investigator per RECIST version 1.1, from the first IPN01203 administration throughout the study.
10. 10. Time to response (TTR). TTR is defined as the time between date of start of treatment until first documented response (CR or PR), as determined by investigator per RECIST version 1.1.
11. 11. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ipsen Pharma

Sponsor organisation

Ipsen Pharma

Address

70 Rue Balard

City

Paris

Postcode

75015

Country

France

Scientific contact point

Organisation

Ipsen Pharma

Contact name

Ipsen Clinical Study Enquiries

Public contact point

Organisation

Ipsen Pharma

Contact name

Ipsen Clinical Study Enquiries

Third parties 9

Locations

2 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications