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Solid Tumor, AdultPhase 1/2NCT06622486

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

A Phase 1/2 study testing EGL-001 in people with Solid Tumor, Adult, run by Egle Therapeutics at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
EGL-001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
8 sitesin 2 countries
Study dates
27 Sep 2024to 23 Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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 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
  • 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

Who cannot join

  • 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 exceptions. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
  • Patients with history of or current interstitial lung disease or fibrosis, and patients with pneumonitis
  • Other active malignancy requiring active intervention
Show all 14Show fewer
  • 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 investigator
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pejvack Motlagh, MD contact

33660462343

contact@egle-tx.com

8 sites in 2 countries

France4 sites, 4 recruiting

  • Centr Georges Francois Leclerc

    Dijon

    Alice HERVIEU, MD, +33380737506, ahervieu@cgfl.fr

    Not yet recruiting

  • Institut Regional Du Cancer De Montpellier

    Montpellier

    Diego TOSI, MD, +33467612304, diego.tosi@icm.unicancer.fr

    Recruiting

  • Institut Curie

    Paris

    Christophe LE TOURNEAU, MD, +33144324086, christophe.letourneau@curie.fr

    Recruiting

  • Institut Gustave Roussy

    Paris

    Aurélien MARABELLE, MD, +33142115592, aurelien.marabelle@gustaveroussy.fr

    Not yet recruiting

Other trials in France

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona

    Elena GARRALDA CABANAS, MD, +34932746085, egarralda@vhio.net

    Not yet recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

    Victor MORENO GARCIA, MD, +34915504800, victor.moreno@startmadrid.com

    Not yet recruiting

  • Clinica Universidad De Navarra

    Pamplona

    Ana LANDA MAGDALENA, MD, +34948255400, alandam@unav.es

    Not yet recruiting

  • Hospital Clinico Universitario De Valencia

    Valencia

    Valentina GAMBARDELLA, MD, +34691135106, Valen.gambardella@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: First-in-human Phase 1/2 Trial of EGL-001 in Adult Patients with Selected Advanced And/or Metastatic Solid Tumors

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.

Being tested
EGL-001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGL-001Drug

    IV administration

Study groups in NCT06622486
Study groupRoleWhat they receive
Monotherapy EGL-001 Dose Level 1ExperimentalEGL-001 Dose Level 1
Receives: Drug: EGL-001
Monotherapy EGL-001 Dose Level 2ExperimentalEGL-001 Dose Level 2
Receives: Drug: EGL-001
Monotherapy EGL-001 Dose Level 3ExperimentalEGL-001 Dose Level 3
Receives: Drug: EGL-001
Monotherapy EGL-001 Dose Level 4ExperimentalEGL-001 Dose Level 4
Receives: Drug: EGL-001
Monotherapy EGL-001 Dose Level 5ExperimentalEGL-001 Dose Level 5
Receives: Drug: EGL-001
Monotherapy EGL-001 Dose Level 6ExperimentalEGL-001 Dose Level 6
Receives: Drug: EGL-001
Monotherapy EGL-001 Dose Level 7ExperimentalEGL-001 Dose Level 7
Receives: Drug: EGL-001
Combination therapy with EGL-001 dose Level xExperimentalEGL-001 Dose Level x in combination with anti-PDL1
Receives: Drug: EGL-001
Combination therapy with EGL-001 dose Level yExperimentalEGL-001 Dose Level y in combination with anti-PDL1
Receives: Drug: EGL-001
Combination therapy with EGL-001 dose Level zExperimentalEGL-001 Dose Level z in combination with anti-PDL1
Receives: Drug: EGL-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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) (%)

    Measured: 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) (%)

    Measured: 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) (%)

    Measured: Day 1 up to 90 days after last dose

Secondary outcomes (5)

  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. (%)

    Measured: 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 (%)

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start27 Sep 2024
  3. Primary completion23 Jan 2027 (estimated)
  4. Study completion23 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation followed by combination therapy
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06622486
Sponsor's protocol ID
EGL-121
Other IDs
2024-512921-10-00
Status last verified
Nov 2024
First submitted
26 Sep 2024
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EGL-001 in people with Solid Tumor, Adult, run by Egle Therapeutics at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pejvack Motlagh, MD (33660462343, contact@egle-tx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds) (time frame: Day 1 up to 90 days after last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06622486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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