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

Metastatic Breast Cancer Clinical Trial

— AIPAC-002  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04252768
• Other study ID #: P018
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2023
• Est. completion date: February 2026

Study information

• Verified date: March 2023
• Source: Immutep S.A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Immutep S.A.S.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC of efti given on the same day as paclitaxel	AUC after 1st injection of efti	up to 12 month
Secondary	Cmax of efti given on the same day as paclitaxel	Cmax after 1st injection of efti	up to 12 month
Secondary	Tmax of efti given on the same day as paclitaxel	Tmax after 1st injection of efti	up to 12 month
Secondary	Peripheral IFN-gamma concentration in the blood	Changes IFN-gamma concentration in course of treatment with efti	up to 12 month
Secondary	Peripheral IP-10 concentration in the blood	Changes IP-10 concentration in course of treatment with efti	up to 12 month
Secondary	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
Secondary	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
Secondary	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
Secondary	To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day	Screen for possible ADA	up to 12 month