Informations générales (source: ClinicalTrials.gov)
First-in-human Phase 1/2 Trial of EGL-001 in Adult Patients with Selected Advanced And/or Metastatic Solid Tumors
Interventional
Phase 1/Phase 2
Egle Therapeutics (Voir sur ClinicalTrials)
septembre 2024
janvier 2027
08 novembre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Christophe LE TOURNEAU, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centr Georges Francois Leclerc - Dijon - France | Alice HERVIEU, MD | Contact (sur clinicalTrials) | |||
| Institut Gustave Roussy - Paris - France | Aurélien MARABELLE, MD | Contact (sur clinicalTrials) | |||
| Institut Regional Du Cancer De Montpellier - Montpellier - France | Diego TOSI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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