Actively Recruiting
Safety and Early Signs of Efficacy of IL12-L19L19.
Led by Philogen S.p.A. · Updated on 2026-01-14
80
Participants Needed
11
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to describe the safety, tolerability and early signs of efficacy of the antibody-cytokine fusion protein IL12-L19L19 in patients with advanced or metastatic solid carcinomas, after previous immune checkpoint blockade therapy. The primary objective of the study is to evaluate the safety of IL12-L19L19 and to establish MTD in order to establish a recommended dose (RD). The secondary objectives of the study are to assess early signs of efficacy, the determination of pharmacokinetic (PK) properties and the immunogenicity of IL12-L19L19.
CONDITIONS
Official Title
Safety and Early Signs of Efficacy of IL12-L19L19.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years at the time of consent
- Histological or cytological diagnosis of advanced or metastatic solid carcinoma responsive to immunotherapy, progressed after immune checkpoint blockade
- Prior treatment with immune checkpoint blockade therapy
- No other treatments with curative or survival-prolonging potential available per investigator
- Clinical benefit from checkpoint inhibitor treatment with disease control for at least 3 months before progression
- Progressive disease or relapse at screening
- Prior chemotherapy, immunotherapy, or radiation completed at least 4 weeks before study drug; limited palliative radiation allowed within 4 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Estimated life expectancy of at least 12 weeks
- At least one measurable tumor lesion by CT, MRI, or PET/CT
- Negative test for HIV, HBV, and HCV infections as specified
- All acute toxic effects from prior therapies resolved to Grade 1 or less (excluding alopecia and fatigue)
- Full resolution of checkpoint blockade therapy-related adverse effects for at least 4 weeks prior to enrollment, except stable hypothyroidism or hypophysitis on stable maintenance therapy
- No history of severe immune-related adverse effects from prior checkpoint therapy
- Female patients of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Male patients able to father children must agree to use two methods of contraception during the study
- Negative tuberculosis test
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Participation in investigational drug or device study within 4 weeks prior to treatment
- Radiotherapy within 4 weeks prior to treatment start (except limited palliative radiation)
- Active or history of autoimmune disease that could worsen with immunostimulatory agents
- Primary brain tumors or central nervous system disease, including brain metastases
- Use of herbal medications within 7 days prior to treatment
- Known allergy to study medication components or similar intravenously administered proteins
- Low blood counts: neutrophils, platelets, or hemoglobin below specified thresholds
- Poor kidney function or elevated creatinine
- Inadequate liver function as defined by lab values, with exceptions for liver metastasis
- Severe concomitant conditions or risk factors making participation undesirable
- Recent cerebrovascular or acute coronary events within one year
- Heart failure above Grade II or significant cardiac arrhythmias
- Abnormal heart function or QT prolongation on ECG or echocardiogram
- Uncontrolled high blood pressure measured on multiple occasions
- Severe ischemic peripheral vascular disease
- Severe diabetic retinopathy
- Major surgery or trauma within 4 weeks before treatment
- Pregnancy or breastfeeding
- Systemic steroid therapy above 10 mg/day prednisone or equivalent within 14 days prior
- Active uncontrolled infections or severe concurrent diseases
- Other malignancies within 2 years unless in complete remission
- Use of growth factors or immunomodulatory agents within 7 days prior
- Serious non-healing wounds, ulcers, or fractures
- Recent blood clots or vascular events within 6 months
- Concurrent use of other anti-cancer treatments besides study drug
- Recent live vaccinations within 4 weeks or planned during study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Universitaetsklinik Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
Actively Recruiting
2
Universitätsklinikum Heidelberg, Nationalen Centrum für Tumorerkrankungen (NCT), Dermatoonkologie
Heidelberg, Heidelberg, Germany, 69120
Actively Recruiting
3
Universitätsklinikum Leipzig, Klinik für Dermatologie, Venerologie und Allergologie
Leipzig, Leipzig, Germany, 04103
Actively Recruiting
4
Universitätsklinikum Tübingen, Klinik für Innere Medizin VIII Medizinische Onkologie und Pneumologie
Tübingen, Germany, 72076
Actively Recruiting
5
IEO - Istituto Europeo di Oncologia
Milan, Italy, Italy
Actively Recruiting
6
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
7
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Italy
Not Yet Recruiting
8
Universitätsspital Basel
Basel, Basel, Switzerland, CH-4031
Actively Recruiting
9
Insel Gruppe AG
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
10
Geneva University Hospital, Oncology Department
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
11
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, 6500
Actively Recruiting
Research Team
J
Jacqueline Mock, PhD
CONTACT
F
Federica Bastioli, Pharmaceutical Chemist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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