Trial Title:
First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors
NCT ID:
NCT06622486
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Dose escalation followed by combination therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EGL-001
Description:
IV administration
Arm group label:
Combination therapy with EGL-001 dose Level x
Arm group label:
Combination therapy with EGL-001 dose Level y
Arm group label:
Combination therapy with EGL-001 dose Level z
Arm group label:
Monotherapy EGL-001 Dose Level 1
Arm group label:
Monotherapy EGL-001 Dose Level 2
Arm group label:
Monotherapy EGL-001 Dose Level 3
Arm group label:
Monotherapy EGL-001 Dose Level 4
Arm group label:
Monotherapy EGL-001 Dose Level 5
Arm group label:
Monotherapy EGL-001 Dose Level 6
Arm group label:
Monotherapy EGL-001 Dose Level 7
Summary:
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.
Detailed description:
In approximately 4 centers in France and 4 centers in Spain, 30 to 50 patients will be
included in the dose escalation Part 1 of the trial. Number of participating countries
and sites as well as patients will be defined based on Part 1 for Part 2 dose expansion
phase.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed written informed consent
2. Female or male patients, aged at least 18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Life expectancy of at least 3 months as assessed by the investigator
5. Patients with confirmed locally advanced, unresectable, or metastatic solid tumors
who have been previously treated with SoC and are no longer eligible for other
therapies
6. Patients who have been treated with an ICI treatment as monotherapy or in
combination as SoC
7. Have recovered from previous treatment
8. At least 1 measurable lesion according to RECIST Version 1.1
9. Adequate hematological, hepatic, and renal functions
10. Negative blood pregnancy test at screening for women of childbearing potential
11. Highly effective contraception during the study period and for 6 months after the
last study treatment administration for WOCBP, and for male patients who are
sexually active with WOCBP. Highly effective contraception methods are defined as:
- Hormonal methods of contraception including combined oral contraceptive pills,
vaginal ring, injectable, implants, intrauterine devices such as Mirena and
nonhormonal intrauterine devices such as ParaGard for WOCBP patients or male
patients' WOCBP partners
- Tubal ligation
- Vasectomy
In addition to highly effective contraception, participating male patients:
- Must use a condom during the study period and for 3 months after the last study
treatment administration when engaging in any activity that allows for exposure
to ejaculate
- Must refrain from donating sperm
12. Must agree to abstain from donating blood while taking study drug and for 3 months
following discontinuation of study treatment
13. Able to understand the character and individual consequences of clinical trial
Exclusion Criteria:
1. Patients with central nervous system metastases and/or leptomeningeal carcinomatosis
with some exceptions
2. Patients with active or a documented history of autoimmune disease, immune
deficiency or syndrome that required systemic corticoids (except the allowed dose)
or immunosuppressive medications
3. Patients who received a previous ICI like anti-PD(L)-1 or an agent directed to
another stimulatory or co-inhibitory T-cell receptor and was discontinued from that
treatment due to toxicity
4. Patients under chronic treatment with systemic corticosteroids or other
immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not
stopped 2 weeks prior to the first study treatment, with exceptions. Steroids with
no or minimal systemic effect (topical, inhalation) are allowed
5. Patients with history of or current interstitial lung disease or fibrosis, and
patients with pneumonitis
6. Other active malignancy requiring active intervention
7. Patients with previous malignancies other than the target malignancy to be
investigated in this trial, unless a complete remission was achieved and no
additional therapy is required during the study period
8. Patient with any organ transplantation, including allogeneic stem cell
transplantation
9. Known severe hypersensitivity reactions to monoclonal antibodies, any history of
anaphylaxis, or uncontrolled asthma
10. Any known allergy or severe reaction to any component of anti-CTLA-4 or anti-PD(L)-1
drug product
11. Significant chronic or acute infections requiring systemic therapy including
SARS-CoV-2 (COVID-19) PCR positive testing
12. Clinically significant active cardiovascular disease
13. Any other medical conditions or psychological disorders that would increase the
safety risk to the patient or interfere with participation of the patient or the
evaluation of the clinical study in the opinion of the investigator
14. Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centr Georges Francois Leclerc
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alice HERVIEU, MD
Phone:
+33380737506
Email:
ahervieu@cgfl.fr
Facility:
Name:
Institut Regional Du Cancer De Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
Diego TOSI, MD
Phone:
+33467612304
Email:
diego.tosi@icm.unicancer.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Christophe LE TOURNEAU, MD
Phone:
+33144324086
Email:
christophe.letourneau@curie.fr
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurélien MARABELLE, MD
Phone:
+33142115592
Email:
aurelien.marabelle@gustaveroussy.fr
Facility:
Name:
Hospital Universitari Vall D Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Elena GARRALDA CABANAS, MD
Phone:
+34932746085
Email:
egarralda@vhio.net
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Victor MORENO GARCIA, MD
Phone:
+34915504800
Email:
victor.moreno@startmadrid.com
Facility:
Name:
Clinica Universidad De Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ana LANDA MAGDALENA, MD
Phone:
+34948255400
Email:
alandam@unav.es
Facility:
Name:
Hospital Clinico Universitario De Valencia
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Valentina GAMBARDELLA, MD
Phone:
+34691135106
Email:
Valen.gambardella@gmail.com
Start date:
September 27, 2024
Completion date:
January 23, 2027
Lead sponsor:
Agency:
Egle Therapeutics
Agency class:
Industry
Source:
Egle Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06622486
