NCT06622486

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
8mo left

Started Sep 2024

Typical duration for phase_1

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2024Jan 2027

First Submitted

Initial submission to the registry

September 26, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2027

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

September 26, 2024

Last Update Submit

November 5, 2024

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (4)

  • 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)

    Day 1 up to 90 days after last dose

  • 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) (%)

    Day 1 up to 90 days after last dose

  • 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) (%)

    Day 1 up to 90 days after last dose

  • 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) (%)

    Day 1 up to 90 days after last dose

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

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

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

Study Arms (10)

Monotherapy EGL-001 Dose Level 1

EXPERIMENTAL

EGL-001 Dose Level 1

Drug: EGL-001

Monotherapy EGL-001 Dose Level 2

EXPERIMENTAL

EGL-001 Dose Level 2

Drug: EGL-001

Monotherapy EGL-001 Dose Level 3

EXPERIMENTAL

EGL-001 Dose Level 3

Drug: EGL-001

Monotherapy EGL-001 Dose Level 4

EXPERIMENTAL

EGL-001 Dose Level 4

Drug: EGL-001

Monotherapy EGL-001 Dose Level 5

EXPERIMENTAL

EGL-001 Dose Level 5

Drug: EGL-001

Monotherapy EGL-001 Dose Level 6

EXPERIMENTAL

EGL-001 Dose Level 6

Drug: EGL-001

Monotherapy EGL-001 Dose Level 7

EXPERIMENTAL

EGL-001 Dose Level 7

Drug: EGL-001

Combination therapy with EGL-001 dose Level x

EXPERIMENTAL

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

Drug: EGL-001

Combination therapy with EGL-001 dose Level y

EXPERIMENTAL

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

Drug: EGL-001

Combination therapy with EGL-001 dose Level z

EXPERIMENTAL

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

Drug: EGL-001

Interventions

EGL-001DRUG

IV administration

Combination therapy with EGL-001 dose Level xCombination therapy with EGL-001 dose Level yCombination therapy with EGL-001 dose Level zMonotherapy EGL-001 Dose Level 1Monotherapy EGL-001 Dose Level 2Monotherapy EGL-001 Dose Level 3Monotherapy EGL-001 Dose Level 4Monotherapy EGL-001 Dose Level 5Monotherapy EGL-001 Dose Level 6Monotherapy EGL-001 Dose Level 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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 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:
  • +4 more criteria

You may not qualify 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 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

Study Officials

  • Pejvack Motlagh, MD

    Egle Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Pejvack Motlagh, MD

CONTACT

33660462343contact@egle-tx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose escalation followed by combination therapy
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 2, 2024

Study Start

September 27, 2024

Primary Completion (Estimated)

January 23, 2027

Study Completion (Estimated)

January 23, 2027

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

FR(4)ES(4)