Actively Recruiting
First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors
Led by Egle Therapeutics · Updated on 2024-11-07
50
Participants Needed
8
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, open-label, first-in-human, Phase 1/2 study consists of a Part 1 (Phase 1) open-label dose escalation of EGL-001 administered as a single agent and in combination with an anti-PD(L)-1 treatment, followed by a Part 2 (Phase 2) open-label dose expansion of EGL-001 administered at the RP2D in patients with recurrent and/or metastatic solid tumors as monotherapy and/or combination therapy with anti-PD(L)-1.
CONDITIONS
Official Title
First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Adult male or female patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Confirmed locally advanced, unresectable, or metastatic solid tumors previously treated with standard care and no longer eligible for other therapies
- Prior treatment with immune checkpoint inhibitor (ICI) therapy as monotherapy or combination
- Recovery from previous treatments
- At least one measurable lesion according to RECIST Version 1.1
- Adequate blood, liver, and kidney function
- Negative pregnancy test at screening for women who can become pregnant
- Use of highly effective contraception during the study and for 6 months after last treatment for women of childbearing potential and sexually active male patients with such partners
- Agreement to avoid blood donation during treatment and for 3 months after
- Ability to understand the nature and consequences of the clinical trial
You will not qualify if you...
- Patients with central nervous system metastases or leptomeningeal carcinomatosis (with some exceptions)
- Active or history of autoimmune disease, immune deficiency, or syndrome requiring systemic corticosteroids or immunosuppressive drugs
- Previous immune checkpoint inhibitor treatment stopped due to toxicity
- Chronic use of systemic corticosteroids or immunosuppressants not stopped at least 2 weeks before study start (exceptions apply)
- History of interstitial lung disease, fibrosis, or pneumonitis
- Other active cancers requiring treatment
- Previous cancers other than the target tumor unless in complete remission without further therapy
- Any organ transplantation including stem cell transplantation
- Severe allergies to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma
- Allergy or severe reaction to anti-CTLA-4 or anti-PD(L)-1 drugs
- Serious infections requiring treatment, including positive COVID-19 test
- Significant active heart disease
- Any other medical or psychological conditions that increase safety risks or interfere with the study
- Pregnant, breastfeeding, or planning to conceive or father children during the study period
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Centr Georges Francois Leclerc
Dijon, France
Not Yet Recruiting
2
Institut Regional Du Cancer De Montpellier
Montpellier, France
Actively Recruiting
3
Institut Curie
Paris, France
Actively Recruiting
4
Institut Gustave Roussy
Paris, France
Not Yet Recruiting
5
Hospital Universitari Vall D Hebron
Barcelona, Spain
Not Yet Recruiting
6
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Not Yet Recruiting
7
Clinica Universidad De Navarra
Pamplona, Spain
Not Yet Recruiting
8
Hospital Clinico Universitario De Valencia
Valencia, Spain
Actively Recruiting
Research Team
P
Pejvack Motlagh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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