A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

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

30 May 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ipsen Pharma

External identifiers

EU CT number

2024-519184-18-00

ClinicalTrials.gov

NCT06833008

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

Part A Dose Escalation
• To evaluate safety and tolerability of IPN01195 and determine the MTD/MAD.
• To determine the pharmacologically active dose range of IPN01195.
Part B Dose Confirmation
• To determine the optimal dose of IPN01195 in selected tumour type(s).

Secondary objectives 7

1. Part A: To characterise the PK of IPN01195.
2. Part A: To evaluate the effect of food on IPN01195 PK.
3. Part A: To quantify the relationship between IPN01195 exposure and potential prolongation of QT interval at clinically relevant concentrations.
4. Part A: To assess the preliminary clinical benefit of IPN01195 by evaluation of anti-tumour activity.
5. Part B: To estimate DoR for each selected tumour type.
6. Part B: To estimate the PFS and the PFS rate at 4 months for each selected tumour type.
7. Part B: To estimate DCR for each selected tumour type.

Conditions and MedDRA coding

Advanced Solid Tumour

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participants must be ≥18 years of age or the country’s legal age of majority if the legal age is more than 18 years at the time of signing the informed consent.
2. Participants with confirmed diagnosis of advanced or unresectable or recurrent solid tumor who have progressed on prior standard treatment or could not tolerate or are not eligible for standard treatment, or for whom no standard treatment to improve the disease outcome is available
3. Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
4. Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.
5. Part B: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for MAPK genomic testing to confirm eligibility.
6. Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
7. Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1
8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria 18

1. Gastrointestinal conditions that could impair absorption of IPN01195 (specific cases e.g. remote history of gastrointestinal surgery, may be enrolled after discussion with the medical monitor)
2. Any evidence of severe active infection or inflammatory condition.
3. Non-adequate cardiac function
4. Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant’s ability to cooperate with the requirements of the study.
5. Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will obscure the interpretation of toxicity determination or AEs.
6. Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.
7. Active brain metastases or leptomeningeal
8. Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days
9. Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.
10. Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
11. Washout period of less than 28 days prior anti-cancer therapy (including chemotherapy, targeted agents, radiotherapy). If the participant was treated with an agent having a short half-life, washout can be <28 days but not shorter than 5 times the half-life.
12. Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of the study intervention.
13. Non-adequate bone marrow function
14. Non-adequate renal function
15. Non-adequate hepatic function
16. Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.
17. Known uncontrolled or untreated hepatitis infection. (a) Known uncontrolled hepatitis B virus (HBV) infection. (b) Known untreated current hepatitis C virus (HCV) infection.
18. Sensitivity to IPN01195 or any of its components.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Part A: Percentage of participants with dose limiting toxicity (DLT) [Time Frame: Part A: within 28 days of first dose.]
2. Part A and B: Percentage of participants experiencing emergent serious adverse events (TE SAEs). [Time Frame: From the first IPN01195 administration to 30 days after last dose.]
3. Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations [Time Frame: From the first study drug administration to 30 days after last dose.]
4. Part B: Objective response rate (ORR) Objective response rate is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1. [Time Frame: Part B: At end of study (up to approximately 3 years)]

Secondary endpoints 12

1. Part A: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01195 [Time Frame: Cycle 1: at Day 1 and at Day 15.]
2. Part A: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01195 [Time Frame: Cycle 1: at Day 1 and at Day 15.]
3. Part A: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01195 AUCtau is defined as the concentration of drug over one dosing interval. [Time Frame: Cycle 1: at Day 1 and at Day 15.]
4. Part A: Geometric mean ratio of Cmax of IPN01195 administered in fed state relative to fasted state. [Time Frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)]
5. Part A: Geometric mean ratio of AUClast of IPN01195 administered in fed state relative to fasted state AUClast is defined as the concentration of drug from time zero to the last observable concentration. [Time Frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)]
6. Part A: Geometric mean ratio of AUCinf of IPN01195 administered in fed state relative to fasted state AUCinf is defined as the concentration of drug extrapolated to infinite time. [Time Frame: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)]
7. Part A: Prolongation of corrected QT interval (QTc) Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure. [Time Frame: Within 28 days of first dose.]
8. Part A: Objective response rate (ORR) The ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1 [Time Frame: Part A: From first study drug administration to end of study (up to approximately 3 years)]
9. Part B: Duration of response (DoR) DoR defined as the time from first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1. [Time Frame: Every 3 months until end of study or death (up to approximately 3 years)]
10. Part B: Progression-free survival (PFS) PFS is defined as the time from the date of first IPN01195 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1. [Time Frame: From first study drug administration to end of study (up to approximately 3 years)]
11. Part B: PFS rate at 4 months PFS rate at 4 months defined as the proportion of participants who remain alive and progression-free at 4 months, as determined by investigator per RECIST version 1.1. [Time Frame: At Month 4]
12. Part B: Disease control rate (DCR). DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1 [Time Frame: Part B:From first study drug administration to end of study (up to approximately 3 years)]

Investigational products

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

Test 2

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 14

Locations

3 EU/EEA countries · 8 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 25 files

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

Application history

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