Advanced Solid TumorPhase 1/2NCT06833008
A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
A Phase 1/2 study testing IPN01195 in people with Advanced Solid Tumor, run by Ipsen at 13 sites in 4 countries.
Trial summary
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- IPN01195
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 14 Mar 2025to 4 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.
- Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
- 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.
- 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.
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
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- Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 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.
Who cannot join
- 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)
- Any evidence of severe active infection or inflammatory condition.
- Non-adequate cardiac function
- 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.
- Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.
- Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.
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- Active brain metastases or leptomeningeal
- Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days
- Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.
- Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
- 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.
- 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.
- Non-adequate bone marrow function
- Non-adequate renal function
- Non-adequate hepatic function
- Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.
- Known uncontrolled or untreated hepatitis infection.
- (a) Known uncontrolled hepatitis B virus (HBV) infection.
- (b) Known untreated current hepatitis C virus (HCV) infection.
- Sensitivity to IPN01195 or any of its components.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States5 sites
Mary Crowley Cancer Research Centers - Medical City Hospital - Dallas
Dallas, Texas, 75230
Virginia Cancer Specialist- Fairfax
Fairfax, Virginia, 22031
START Mid-West
Grand Rapids, Michigan, 49546
Sarah Cannon Research Institute (SCRI) - Nashville
Nashville, Tennessee, 37203
START Mountan Region
West Valley City, Utah, 84119
France3 sites
Centre Léon Bérard - Lyon
Lyon
Paris Saint-Louis
Paris
IGR-Villejuif
Villejuif
Spain3 sites
Val D'Hebron
Barcelona
Hospital Universitario Quirónsalud Madrid
Madrid
M.D. Anderson Center Madrid
Madrid
Italy2 sites
Istituto Nazionale dei Tumori
Milan
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples
About this study
Official title: An Open-label, Phase I/II First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
Read the detailed description
The study consists of two phases, called phase I and phase II.
Phase I will be conducted in two parts:
Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195.
Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a "low dose" or "high dose" and further explore the safety and tolerability.
These parts will consist of the following periods:
- A period to assess eligibility (screening period).
- A treatment period that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at 30 days after the last administration of study drug.
An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away.
Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug.
In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
- Conditions
- Advanced Solid Tumor
- Being tested
- IPN01195
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPN01195Drug
IPN01195 will be administered at assigned dose level.
| Study group | Role | What they receive |
|---|---|---|
| Part A (dose escalation) | Experimental | IPN01195 will be administered at assigned dose level. Receives: Drug: IPN01195 |
| Part B - (randomisation) | Experimental | Participants will be randomised to one of the two doses of interest once the PADR is determined Receives: Drug: IPN01195 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Percentage of participants with dose limiting toxicity (DLT)
Measured: Part A: within 28 days of first dose.
Part A and B: Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs).
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.
Measured: From the first IPN01195 administration to 30 days after last dose.
Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations
Measured: From the first study drug administration to 30 days after last dose.
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.
Measured: Part B: At end of study (up to approximately 3 years)
Secondary outcomes (12)
Part A: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01195
Measured: Cycle 1: at Day 1 and at Day 15.
Part A: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01195
Measured: Cycle 1: at Day 1 and at Day 15.
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.
Measured: Cycle 1: at Day 1 and at Day 15.
Part A: Geometric mean ratio of Cmax of IPN01195 administered in fed state relative to fasted state.
Measured: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
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.
Measured: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
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.
Measured: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
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.
Measured: Within 28 days of first dose.
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
Measured: Part A: From first study drug administration to end of study (up to approximately 3 years)
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.
Measured: Every 3 months until end of study or death (up to approximately 3 years)
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.
Measured: From first study drug administration to end of study (up to approximately 3 years)
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.
Measured: At Month 4
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
Measured: Part B:From first study drug administration to end of study (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start14 Mar 2025
- Primary completion4 Apr 2028 (estimated)
- Study completion4 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833008
- Sponsor's protocol ID
- CLIN-01195-450
- Other IDs
- 2024-519184-18-00
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I/II First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06833008
- Acronym / sponsor ID
- CLIN-01195-450
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 4 Apr 2028 (estimated)
- Study completion
- 4 Apr 2028 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
Detailed description
The study consists of two phases, called phase I and phase II.
Phase I will be conducted in two parts:
Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195.
Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a "low dose" or "high dose" and further explore the safety and tolerability.
These parts will consist of the following periods:
- A period to assess eligibility (screening period).
- A treatment period that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at 30 days after the last administration of study drug.
An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away.
Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug.
In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A (dose escalation) | Experimental | Drug: IPN01195IPN01195 will be administered at assigned dose level. |
| Part B - (randomisation) | Experimental | Drug: IPN01195Participants will be randomised to one of the two doses of interest once the PADR is determined |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.
- Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
- 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.
- 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.
Key exclusion criteria (20 listed)
- 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)
- Any evidence of severe active infection or inflammatory condition.
- Non-adequate cardiac function
- 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.
- Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPN01195IPN01195 will be administered at assigned dose level. | Drug | Part A (dose escalation), Part B - (randomisation) |
Primary outcome
Part A: Percentage of participants with dose limiting toxicity (DLT)
Time frame: Part A: within 28 days of first dose.
Part A and B: Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs).
Time frame: From the first IPN01195 administration to 30 days after 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.
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.
Part B: Objective response rate (ORR)
Time frame: Part B: At end of study (up to approximately 3 years)
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.
12 secondary outcomes
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.
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.
Part A: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01195
Time frame: Cycle 1: at Day 1 and at Day 15.
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)
Part A: Geometric mean ratio of AUClast 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)
Part A: Geometric mean ratio of AUCinf 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)
Part A: Prolongation of corrected QT interval (QTc)
Time frame: Within 28 days of first dose.
Part A: Objective response rate (ORR)
Time frame: Part A: From first study drug administration to end of study (up to approximately 3 years)
Part B: Duration of response (DoR)
Time frame: Every 3 months until end of study or death (up to approximately 3 years)
Part B: Progression-free survival (PFS)
Time frame: From first study drug administration to end of study (up to approximately 3 years)
Part B: PFS rate at 4 months
Time frame: At Month 4
Part B: Disease control rate (DCR).
Time frame: Part B:From first study drug administration to end of study (up to approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPN01195 in people with Advanced Solid Tumor, run by Ipsen at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Percentage of participants with dose limiting toxicity (DLT) (time frame: Part A: within 28 days of first dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.