Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy

NCT05747794 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: AIPAC-0032022-003323-17
• Study Type: interventional
• Target: 849
• Locations: 5 countries
• Sites: 22

Brief Summary

The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are:

• What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy?
• Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone? In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled). The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (10)

• Determination of Overall survival (OS)

  Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months

• Determination of the Optimal Biological Dose (OBD)

  Up to 15 months

• Frequency of adverse events (AEs)

  Up to 15 months

• Severity of adverse events (AEs)

  Up to 15 months

• Duration of adverse events (AEs)

  Up to 15 months

• Occurrence of dose-limiting toxicities (DLTs)

  Up to 15 months

• Occurrence of clinically relevant abnormalities in vital signs

  Up to 15 months

• Occurrence of clinically relevant abnormalities in physical examinations

  Up to 15 months

• Occurrence of clinically relevant abnormalities in 12-lead ECGs

  Up to 15 months

• Occurrence of clinically relevant abnormalities in safety laboratory assessments

  Up to 15 months

Secondary Outcomes (9)

• Determination of Progression Free Survival (PFS), based on RECIST, v1.1

  Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months

• Evaluation of Objective Response Rate (ORR) based on RECIST v1.1

  Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months

• Changes from baseline in quality of life (QOL) as assessed by questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

  Up to 13 months

• PK parameter: area under the curve (AUC) (dose optimization lead-in only)

  Up to 4 months

• PK parameter: peak serum concentration (Cmax) (dose optimization lead-in only)

  Up to 4 months

Study Arms (4)

open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel

EXPERIMENTAL

eftilagimod alpha 30mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Biological: eftilagimod alpha; Drug: Paclitaxel

open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel

EXPERIMENTAL

eftilagimod alpha 90mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Biological: eftilagimod alpha; Drug: Paclitaxel

Phase 3: eftilagimod alpha + paclitaxel

EXPERIMENTAL

eftilagimod alpha s.c. (OBD) + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Biological: eftilagimod alpha; Drug: Paclitaxel

Phase 3: placebo + paclitaxel

PLACEBO COMPARATOR

placebo s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Drug: Paclitaxel; Other: placebo

Interventions

eftilagimod alpha BIOLOGICAL

APC activator, MHC II agonist

Also known as: IMP321, efti, LAG-3Ig, eftilagimod alfa

Phase 3: eftilagimod alpha + paclitaxel; open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel; open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel

Paclitaxel DRUG

paclitaxel will be given as standard of care (chemotherapy)

Phase 3: eftilagimod alpha + paclitaxel; Phase 3: placebo + paclitaxel; open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel; open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel

placebo OTHER

placebo matching eftilagimod alpha

Also known as: placebo matching eftilagimod alpha

Phase 3: placebo + paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue
• Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
• Participants with HR- MBC (i.e. triple-negative breast cancer \[TNBC\]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
• ECOG performance status 0-1
• Expected survival longer than three months

You may not qualify if:

• Prior chemotherapy for metastatic breast adenocarcinoma
• Participants with HR+ MBC who have received \<1 line of ET based therapy in the metastatic setting
• Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
• TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
• Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy

Sponsors & Collaborators

• Immutep S.A.S.: lead

Study Sites (22)

The Oncology Institute

Whittier, California, 90602, United States

Location

The George Washington University Cancer Center

Washington D.C., District of Columbia, 20037, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29723, United States

Location

Oncology Consultants

Houston, Texas, 77024, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

AZ Sint-Jan Brugge Oostende av

Bruges, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hopital de Charleroi - Hopital Notre Dame

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuizen Antwerpen

Edegem, 2650, Belgium

Location

Centre Hospitalier de l'Ardenne

Libramont, 6800, Belgium

Location

Clinique Saint-Pierre- Ottignies

Ottignies-Louvain-la-Neuve, Belgium

Location

ARENSIA Exploratory Medicine LLC

Tbilisi, Georgia

Location

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, 2025, Moldova

Location

Institut Català d'Oncologia

Badalona, 08916, Spain

Location

VHIO - Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Parc Taulí Hospital Universitari

Barcelona, 08208, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Jaén

Jaén, 23007, Spain

Location

Unidad Ensayos Clínicos Oncología Fundació IRB Lleida

Lleida, 25196, Spain

Location

START Madrid - FJD, Hospital Fundación Jiménez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

soluble LAG-3 protein, human; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial consists of an open-label dose optimization lead-in component (phase 2) followed by a double-blinded, randomized, placebo-controlled phase 3 component.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 28, 2023
• Study Start: May 22, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); GE (1); ES (9); US (5); BE (6)