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New treatment option for Solid Tumor, Adult
Official title First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06622486
What this study is testing
What is EGL-001?
EGL-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written informed consent
- Female or male patients, aged at least 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months as assessed by the investigator
- Patients with confirmed locally advanced, unresectable, or metastatic solid tumors who have been previously treated with SoC and are no longer...
You likely can't join if
- Patients with central nervous system metastases and/or leptomeningeal carcinomatosis with some exceptions
- Patients with active or a documented history of autoimmune disease, immune deficiency or syndrome that required systemic corticoids (except the...
- 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...
- Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment...
- Patients with history of or current interstitial lung disease or fibrosis, and patients with pneumonitis
- Other active malignancy requiring active intervention
See the full eligibility criteria
- Signed written informed consent
- Female or male patients, aged at least 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months as assessed by the investigator
- 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
- Patients who have been treated with an ICI treatment as monotherapy or in combination as SoC
- Have recovered from previous treatment
- At least 1 measurable lesion according to RECIST Version 1.1
- Adequate hematological, hepatic, and renal functions
- Negative blood pregnancy test at screening for women of childbearing potential
- 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...
- 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...
- 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
- Must agree to abstain from donating blood while taking study drug and for 3 months following discontinuation of study treatment
- Able to understand the character and individual consequences of clinical trial
- Patients with central nervous system metastases and/or leptomeningeal carcinomatosis with some exceptions
- 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
- 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
- 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...
- Patients with history of or current interstitial lung disease or fibrosis, and patients with pneumonitis
- Other active malignancy requiring active intervention
- 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
- Patient with any organ transplantation, including allogeneic stem cell transplantation
- Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
- Any known allergy or severe reaction to any component of anti-CTLA-4 or anti-PD(L)-1 drug product
- Significant chronic or acute infections requiring systemic therapy including SARS-CoV-2 (COVID-19) PCR positive testing
- Clinically significant active cardiovascular disease
- 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...
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
- Montpellier, France
- Paris, France
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France; Montpellier, France; Paris, France; Barcelona, Spain; Madrid, Spain; Pamplona, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.