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IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma | Clinical Trials | Clareo Health

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IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel

NCT02614833•Immutep S.A.S.

View on ClinicalTrials.gov

Summary

The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

Detailed Description

This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages. Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel. Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Able to give written informed consent and to comply with the protocol
•2. Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
•3. Female of age 18 years or above
•4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel
•5. Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1
•6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.

Exclusion Criteria

•1. Prior chemotherapy for metastatic breast adenocarcinoma
•2. Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
•3. Inflammatory carcinoma
•4. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
•5. Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
•6. Symptomatic known cerebral and/or leptomeningeal metastases
•7. Serious intercurrent infection
•8. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
•9. Active acute or chronic infection
•10. Active autoimmune disease requiring immunosuppressive therapy
+3 more criteria

Locations (29)

AZ Sint-Jan Burgge-Oostende

Bruges, Belgium

Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique

Brussels, Belgium

AZ Sint-Maarten

Duffel, Belgium

Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit

Edegem, Belgium

UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre

Leuven, Belgium

Clinique Sainte-Elisabeth

Namur, Belgium

AZ Nikolass

Sint-Niklaas, Belgium

GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research

Wilrijk, Belgium

Institut Curie / Centre René Huguenin

Saint-Cloud, France

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, France

Key Dates

Start Date

December 1, 2015

Primary Completion Date

March 1, 2020

Completion Date

May 1, 2021

Last Updated

October 5, 2021

Enrollment

242

ACTUAL participants

Conditions

Adenocarcinoma Breast Stage IV

Interventions

IMP321 (eftilagimod alpha)

BIOLOGICAL

Placebo

DRUG

Paclitaxel

DRUG