EGL-001 for Advanced solid tumors | Metastatic solid tumors

Inclusion criteria

• {"criterion_text":"- 1. Signed written informed consent.\n- 2. Female or male patients, aged at least 18 years.\n- 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n- 4. Life expectancy of at least 3 months as assessed by the investigator.\n- 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.\n- 6. Patients who have been treated with an ICI treatment as monotherapy or in combination as SoC.\n- 7. Have recovered from previous treatment.\n- 8. At least 1 measurable lesion according to RECIST Version 1.1.\n- 9. Adequate hematological, hepatic, and renal functions.\n- 10. Negative blood pregnancy test at screening for women of childbearing potential.\n- 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.\n- 12. Must agree to abstain from donating blood while taking study drug and for 3 months following discontinuation of study treatment.\n- 13. Able to understand the character and individual consequences of clinical trial."}

Exclusion criteria

• {"criterion_text":"- 1. Patients with central nervous system metastases and/or leptomeningeal carcinomatosis with some exceptions.\n- 2. Patients with active or documented history of autoimmune disease, immune deficiency or syndrome that required systemic corticoids (except the allowed dose) or immunosuppressive medications.\n- 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 were discontinued from that treatment due to toxicity.\n- 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.\n- 5. Patients with history of or current interstitial lung disease or fibrosis, and patients with pneumonitis.\n- 6. Other active malignancy requiring active intervention.\n- 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.\n- 8. Patient with any organ transplantation, including allogeneic stem cell transplantation.\n- 9. Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma.\n- 10. Any known allergy or severe reaction to any component of anti-CTLA-4 or anti-PD(L)-1 drug product.\n- 11. Significant chronic or acute infections requiring systemic therapy including SARS-CoV-2 (COVID-19) PCR positive testing.\n- 12. Clinically significant active cardiovascular disease.\n- 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.\n- 14. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial."}

Primary endpoints

• {"endpoint_text":"- Dose-limiting toxicities (DLTs) when patients are receiving weekly administration of EGL-001 and proportion of patients with adverse events (AEs), treatment-emergent AEs (TEAEs), and serious AEs (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.","definition_or_measurement_approach":"DLTs assessed during weekly administration of EGL-001; AEs/TEAEs/SAEs counted as proportion of patients between first dose and up to 90 days after last dose of study drug (safety reporting window specified)."}
• {"endpoint_text":"- Proportion of patients with complete response (CR) or partial response (PR).","definition_or_measurement_approach":"Tumor response assessed as CR or PR. Measurable disease per inclusion (RECIST Version 1.1) is required, implying response assessment by RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Efficacy assessment based on Overall response rate (ORR), Disease control rate (DCR), Duration of overall response (DoR), Progression-free survival (PFS), Overall survival (OS).","definition_or_measurement_approach":"Efficacy measures (ORR, DCR, DoR, PFS, OS) as standard oncology endpoints; tumor response likely assessed per RECIST v1.1 given inclusion criterion requiring measurable lesion by RECIST 1.1."}
• {"endpoint_text":"- The proportion of patients with adverse events (AEs), treatment-emergent adverse events (TEAEs), and Serious adverse Events (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.","definition_or_measurement_approach":"Proportion of patients experiencing AEs/TEAEs/SAEs during the safety window defined as from first dose until up to 90 days after last dose."}

France

Earliest CTIS Part Ii Submission Date

12-08-2024

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

483

Number Of Sites

4

Number Of Participants

31

Spain

Earliest CTIS Part Ii Submission Date

19-07-2024

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

518

Number Of Sites

4

Number Of Participants

31

Primary sponsor

Full Name

Egle Therapeutics

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Codes: 1,10,11,12,13,2,5,6,7,8 (roles per sponsorDuties listing)

Name

QPS Netherlands B.V.

Responsibilities

Role code: 4 (listed as third party with duty code 4)

Name

Precision For Medicine (UK) Limited

Responsibilities

biomarkers/translational research (test laboratories)

Name

Genewiz Germany GmbH

Responsibilities

biomarkers/translational research (test laboratories)

Third parties

• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"ImmunXperts","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Genewiz Germany GmbH","duties_or_roles":"biomarkers/translational research (test laboratories)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Precision For Medicine (UK) Limited","duties_or_roles":"biomarkers/translational research (test laboratories)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Median Technologies","duties_or_roles":"Collection of CT-scans/images","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}