A Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients to Test a New Schedule of Efti (IMP321, Eftilagimod Alpha) as Adjunctive to a Weekly Treatment Regimen of Paclitaxel

NCT04252768 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: P018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicentre, multinational Phase Ib study in female HR+ MBC patients not receiving Her2-targeted therapy. Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase. The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneously as monotherapy. A total of 24 subjects will be enrolled into the study. The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day

  Severity, frequency and duration of adverse events

  up to 12 month

Secondary Outcomes (9)

• AUC of efti given on the same day as paclitaxel

  up to 12 month

• Cmax of efti given on the same day as paclitaxel

  up to 12 month

• Tmax of efti given on the same day as paclitaxel

  up to 12 month

• Peripheral IFN-gamma concentration in the blood

  up to 12 month

• Peripheral IP-10 concentration in the blood

  up to 12 month

Study Arms (1)

Eftilagimod alpha + Paclitaxel

EXPERIMENTAL

The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneosuly as monotherapy.

Drug: Eftilagimod Alpha; Drug: Paclitaxel

Interventions

Eftilagimod Alpha DRUG

The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneosuly as monotherapy.

Also known as: IMP321; efti

Eftilagimod alpha + Paclitaxel

Paclitaxel DRUG

The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15.

Eftilagimod alpha + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study indication is female metastatic HER2- HR+ breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis
• Subjects who are indicated to receive first line chemotherapy with weekly paclitaxel
• ECOG performance status 0-1
• Expected survival longer than three months

You may not qualify if:

• Prior chemotherapy for metastatic breast adenocarcinoma
• Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
• Prior high-dose chemotherapy requiring hematopoietic stem cell rescue
• Inflammatory carcinoma at time of screening
• Candidate for treatment with trastuzumab (or other Her2/neu targeted agents) or endocrine based therapy according to the applicable treatment guidelines
• Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week or CDK4/6 inhibitors within 5 times half-life (acc. to SPC) prior to first dose of study treatment
• Symptomatic known cerebral and/or leptomeningeal metastases

Sponsors & Collaborators

• Immutep S.A.S.: lead

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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 22, 2023

Record last verified: 2023-03