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RecruitingNCT06622486Updated Nov 7, 2024

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

A Phase 1/2 interventional study of EGL-001 in Solid Tumor, Adult, sponsored by Egle Therapeutics. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Egle Therapeutics · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Solid Tumor, Adult

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Egle Therapeutics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Monotherapy EGL-001 Dose Level 1

    EGL-001 Dose Level 1

    Drug: EGL-001

  • Experimental
    Monotherapy EGL-001 Dose Level 2

    EGL-001 Dose Level 2

    Drug: EGL-001

  • Experimental
    Monotherapy EGL-001 Dose Level 3

    EGL-001 Dose Level 3

    Drug: EGL-001

  • Experimental
    Monotherapy EGL-001 Dose Level 4

    EGL-001 Dose Level 4

    Drug: EGL-001

  • Experimental
    Monotherapy EGL-001 Dose Level 5

    EGL-001 Dose Level 5

    Drug: EGL-001

  • Experimental
    Monotherapy EGL-001 Dose Level 6

    EGL-001 Dose Level 6

    Drug: EGL-001

  • Experimental
    Monotherapy EGL-001 Dose Level 7

    EGL-001 Dose Level 7

    Drug: EGL-001

  • Experimental
    Combination therapy with EGL-001 dose Level x

    EGL-001 Dose Level x in combination with anti-PDL1

    Drug: EGL-001

  • Experimental
    Combination therapy with EGL-001 dose Level y

    EGL-001 Dose Level y in combination with anti-PDL1

    Drug: EGL-001

  • Experimental
    Combination therapy with EGL-001 dose Level z

    EGL-001 Dose Level z in combination with anti-PDL1

    Drug: EGL-001

Interventions

  • DrugEGL-001

    IV administration

06

What researchers measure

Primary outcomes

  1. To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds)

    DLTs occurrence per dose level of EGL-001 during the DLT period (number)

    Time frame: Day 1 up to 90 days after last dose

  2. To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds)

    Proportion of patients with adverse events (AEs) (%)

    Time frame: Day 1 up to 90 days after last dose

  3. To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds)

    Proportion of patients with treatment-emergent AEs (TEAEs) (%)

    Time frame: Day 1 up to 90 days after last dose

  4. To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds)

    Proportion of patients with serious AEs (SAEs) (%)

    Time frame: Day 1 up to 90 days after last dose

Secondary outcomes

  1. To evaluate the preliminary antitumor efficacy (according to RECIST v1.1)

    ORR: the proportion of patients with complete response (CR) or partial response PR), based on local evaluations using RECIST Version 1.1. (%)

    Time frame: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.

  2. To evaluate the preliminary antitumor efficacy (according to RECIST v1.1)

    Disease control rate (DCR): the proportion of patients with CR, PR, or stable disease (SD), and assessment of DCR at 6 months (%)

    Time frame: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.

  3. To evaluate the preliminary antitumor efficacy (according to RECIST v1.1)

    Duration of overall response (DoR): applies only to patients with CR or PR. The start date is the date of first documented response (CR or PR), and the end date is the date of first documented disease progression or the date of death due to underlying cancer (months)

    Time frame: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.

  4. To evaluate the preliminary antitumor efficacy (according to RECIST v1.1)

    PFS: time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first (months)

    Time frame: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.

  5. To evaluate the preliminary antitumor efficacy (according to RECIST v1.1)

    OS: time from the date of first study treatment administration to the date of death due to any cause. If a patient is not known to have died at the cut-off date for analysis, survival will be censored at the date of last contact (months)

    Time frame: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.

07

Study locations

3 of 8 sites recruiting
  • Centr Georges Francois Leclerc
    Dijon, France
    Not yet recruiting
  • Institut Regional Du Cancer De Montpellier
    Montpellier, France
    Recruiting
  • Institut Curie
    Paris, France
    Recruiting
  • Institut Gustave Roussy
    Paris, France
    Not yet recruiting
  • Hospital Universitari Vall D Hebron
    Barcelona, Spain
    Not yet recruiting
  • Hospital Universitario Fundacion Jimenez Diaz
    Madrid, Spain
    Not yet recruiting
  • Clinica Universidad De Navarra
    Pamplona, Spain
    Not yet recruiting
  • Hospital Clinico Universitario De Valencia
    Valencia, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Consequences (RA approval, data protection, operations for datamanagement, impact on IP, on budget...) for sharing IPD are not understood by Egle-Tx. This will be done at a later stage if necessary.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06622486
Lead sponsor
Egle Therapeutics
Responsible party
Sponsor
First posted
Oct 2, 2024
Start date
Sep 27, 2024
Primary completion
Jan 23, 2027 (estimated)
Completion
Jan 23, 2027 (estimated)
Last update
Nov 7, 2024

Study contacts

Pejvack Motlagh, MD
Contact
contact@egle-tx.com
33660462343
Pejvack Motlagh, MD
study director · Egle Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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