Actively Recruiting
A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours
Led by Ipsen · Updated on 2026-04-30
114
Participants Needed
12
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection. Study Phases: * Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance). Study Periods: Screening: Up to 28 days before first IPN60300 injection to determine eligibility. Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor. Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
CONDITIONS
Official Title
A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that relapsed or were refractory after standard therapy, or with no available established therapy, or standard therapy contraindicated or inappropriate
- Measurable disease according to RECIST version 1.1
- ECOG performance status of 0 to 1
- Male and female participants using contraception according to local regulations
- Adequate bone marrow function within 7 days before first study dose
- Adequate renal function within 7 days before first study dose
- Adequate hepatic function or lab values indicating hepatic injury within 7 days before first study dose
- Prothrombin time or INR ≤1.5 times the upper limit of normal
- Tumor tissue specimen available at screening for dose escalation and optimization parts
- Able to provide signed informed consent
- Life expectancy of more than 3 months as assessed by investigator
You will not qualify if you...
- Known second malignancy progressing or requiring active treatment within 2 years before first study dose
- Residual toxicity from prior anticancer therapy of Grade 2 or higher by NCI CTCAE version 5.0 (stable chronic Grade 2 toxicities may be eligible per investigator judgment)
- Major surgery within 4 weeks before first study dose
- Previous solid organ transplantation
- Severe corneal disorders, sequelae from such disorders, or history of corneal transplantation
- Active brain or leptomeningeal metastases except stable, asymptomatic, treated brain metastases under 1.5 cm without neurological symptoms or corticosteroid use
- Stroke or significant cerebrovascular disease within 6 months before study start
- Significant cardiac disease within 6 months before study start, including unstable angina, heart attack, cardiac surgery, or heart failure of NYHA Grade 2 or higher
- Significant respiratory disease within 6 months before study start, including severe COPD or asthma
- History of severe interstitial lung disease or pneumonitis requiring steroids or current ILD/pneumonitis
- Significant gastrointestinal disorders including bleeding, occlusion, diarrhea over Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or partial bowel obstruction
- Severe active infection or inflammatory condition
- Significant uncontrolled medical conditions that increase risk or prevent compliance
- Uncontrolled HIV infection (controlled HIV may be eligible per protocol)
- Active hepatitis B or C infection (eligibility per protocol criteria)
- Ongoing immunosuppressive therapy including systemic corticosteroids (physiologic replacement or topical/inhaled corticosteroids allowed)
- Concurrent participation in another therapeutic treatment trial or recent participation within 5 half-lives or 4 weeks before study start
- Institutionalized due to regulatory or legal order, prisoners, or legally institutionalized
- For French participants: under court protection, lacking social security affiliation, or protected adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Yale Cancer Center-Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Centre Leon Berard
Lyon, France
Actively Recruiting
8
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
Saint-Herblain, France
Not Yet Recruiting
9
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)
Villejuif, France
Actively Recruiting
10
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Not Yet Recruiting
11
NEXT Quiron-Barcelona
Barcelona, Spain
Not Yet Recruiting
12
START Madrid CIOCC Hospital Universitario HM Sanchinarro
Madrid, Spain
Not Yet 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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