Actively Recruiting
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
Led by Ipsen · Updated on 2026-04-30
102
Participants Needed
11
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body. There will be two parts to this study: * Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. * Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability. An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib. Each part will consist of the following periods: * A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first. There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier. In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded. Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Measurable disease per RECIST version 1.1 with locally advanced or metastatic disease confirmed by CT and/or MRI.
- All acute, clinically significant treatment-related adverse events from prior therapy resolved to Grade 1 or lower; chronic Grade 2 or lower neuropathy or alopecia allowed.
- Have a life expectancy as evaluated by the investigator.
- Male and female participants must use contraception according to local regulations.
- Adequate blood and organ function.
- Ability to provide signed informed consent as described in the protocol.
You will not qualify if you...
- Untreated or active primary brain tumor, central nervous system metastases, leptomeningeal disease, or spinal cord compression.
- History of severe, life-threatening immune-mediated adverse events or infusion reactions causing permanent discontinuation of prior anticancer therapy.
- History of known autoimmune disease.
- History of stroke, significant cerebrovascular disease, encephalitis, meningitis, organic brain disease, or uncontrolled seizures within the past year.
- History of clinically significant cardiac disease within 6 months, including unstable angina, myocardial infarction, cardiac surgery, or heart failure of New York Heart Association Grade 2 or higher.
- Left ventricular ejection fraction below 45%.
- QT interval corrected by Fridericia above 470 ms (women) or 450 ms (men) or clinically significant arrhythmias.
- History of clinically significant respiratory disease within 6 months, including severe COPD or asthma.
- Prior organ transplantation.
- Chronic or ongoing active infections within 4 weeks before study drug administration.
- Presence of hepatitis B surface antigen or core antibody, or positive hepatitis C antibody within 3 months prior to first dose.
- Known HIV infection unless meeting specified stability criteria.
- History of other malignancy within the last years.
- Significant uncontrolled medical conditions that increase risk or prevent compliance.
- Treatment with more than 10 mg daily prednisone or other immunosuppressants within 7 days prior, except certain steroid uses.
- Concurrent participation in another therapeutic treatment study.
- Institutionalized due to legal or regulatory order, prisoners, or legally institutionalized individuals.
- For French participants only: under court protection, not affiliated with social security, or protected adults.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
START MidWest PI Sharma
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Sarah Cannon Research Institute PI McKean Nasville, TN, USA
Nashville, Tennessee, United States, 37205
Actively Recruiting
4
MD Anderson PI Champiat
Houston, Texas, United States, 77030
Not Yet Recruiting
5
Start San Antonio PI Rasco
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT PI Spira
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
7
Princess Margaret Cancer Center PI Spreafico
Toronto, Canada
Actively Recruiting
8
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) - PI Ronan
Villejuif, France
Not Yet Recruiting
9
Hospital Universitario Vall d'Hebron PI Garralda Cabanas
Barcelona, Spain
Not Yet Recruiting
10
NEXT Quiron-Barcelona - PI Saavedra Santa Gadea
Barcelona, Spain
Actively Recruiting
11
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC) - Calvo Aller
Madrid, Spain
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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