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 (AIPAC-002)

AIPAC-002 (Active Immunotherapy PAClitaxel-002): A Multicentre, Phase Ib Study to Test a New Schedule of Eftilagimod Alpha (a Soluble LAG-3 Protein) as Adjunctive to Weekly Paclitaxel in Hormone Receptor-positive Metastatic Breast Carcinoma Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Eftilagimod Alpha; Drug: Paclitaxel

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria (selected ones):

• 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

Exclusion Criteria (selected ones):

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Eftilagimod alpha + Paclitaxel; 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; 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.; Other Names: IMP321; efti; Drug: Paclitaxel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of efti given on the same day as paclitaxel	AUC after 1st injection of efti	up to 12 month
Cmax of efti given on the same day as paclitaxel	Cmax after 1st injection of efti	up to 12 month
Tmax of efti given on the same day as paclitaxel	Tmax after 1st injection of efti	up to 12 month
Peripheral IFN-gamma concentration in the blood	Changes IFN-gamma concentration in course of treatment with efti	up to 12 month
Peripheral IP-10 concentration in the blood	Changes IP-10 concentration in course of treatment with efti	up to 12 month
Overall response rate of efti in combination with weekly paclitaxel both given the same day	Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria	up to 12 month
Median progression free survival of efti in combination with weekly paclitaxel both given the same day	The median progression free survival with the use of efti in combination with Paclitaxel	up to 20 month
Median overall survival of efti in combination with weekly paclitaxel both given the same day	The median time frame with overall survival with the use of efti in combination with Paclitaxel	up to 20 month
To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day	Screen for possible ADA	up to 12 month

Collaborators and Investigators

• Sponsor: Immutep S.A.S.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): February 1, 2026

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: P018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No