First-in-human Phase I/II Trial of EGL-001 in Adult Patients with Selected Advanced And/or Metastatic Solid Tumors

Study Identifier:
EGL-121
CT.gov Identifier:
NCT06622486
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-512921-10-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

To evaluate the 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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 1
    • Read More
  • Drug: Drug: EGL-001
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 2
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 3
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 4
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 5
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 6
  • Drug: Experimental: Monotherapy EGL-001 Dose Level 7
  • Drug: Experimental: Combination therapy with EGL-001 dose Level x
  • Drug: Experimental: Combination therapy with EGL-001 dose Level y
  • Drug: Experimental: Combination therapy with EGL-001 dose Level z
  • Drug: The study consists of a Part 1 (Phase 1) dose escalation of EGL-001 administered as a single agent (from 0.3 mg/kg to 12 mg/kg), and in combination with pembrolizumab treatment, according to a BOIN design, followed by a Part 2 (Phase 2) dose expansion of EGL001 administered at the selected doses as monotherapy and/or in combination therapy with anti-PD(L)1
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor