Metastatic Breast CancerPhase 1AIPAC-002NCT04252768
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
A Phase 1 study testing Eftilagimod Alpha and Paclitaxel in people with Metastatic Breast Cancer, run by Immutep S.A.S..
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Eftilagimod Alpha and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Eftilagimod Alpha, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eftilagimod AlphaDrug
Also called IMP321; efti
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.
PaclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Eftilagimod Alpha; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day
Severity, frequency and duration of adverse events
Measured: up to 12 month
Secondary outcomes (9)
AUC of efti given on the same day as paclitaxel
AUC after 1st injection of efti
Measured: up to 12 month
Cmax of efti given on the same day as paclitaxel
Cmax after 1st injection of efti
Measured: up to 12 month
Tmax of efti given on the same day as paclitaxel
Tmax after 1st injection of efti
Measured: up to 12 month
Peripheral IFN-gamma concentration in the blood
Changes IFN-gamma concentration in course of treatment with efti
Measured: up to 12 month
Peripheral IP-10 concentration in the blood
Changes IP-10 concentration in course of treatment with efti
Measured: 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
Measured: 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
Measured: 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
Measured: up to 20 month
To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day
Screen for possible ADA
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startJun 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Replaced by other study NCT05747794
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immutep S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252768
- Sponsor's protocol ID
- P018
- Acronym
- AIPAC-002
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04252768
- Acronym / sponsor ID
- AIPAC-002 / P018
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced by other study NCT05747794
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Immutep S.A.S.Industry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eftilagimod alpha + Paclitaxel | Experimental | Drug: Eftilagimod Alpha, Drug: PaclitaxelThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eftilagimod AlphaAlso: IMP321; eftiThe 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. | Drug | Eftilagimod alpha + Paclitaxel |
| PaclitaxelThe 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. | Drug | Eftilagimod alpha + Paclitaxel |
Primary outcome
Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day
Time frame: up to 12 month
Severity, frequency and duration of adverse events
9 secondary outcomes
AUC of efti given on the same day as paclitaxel
Time frame: up to 12 month
Cmax of efti given on the same day as paclitaxel
Time frame: up to 12 month
Tmax of efti given on the same day as paclitaxel
Time frame: up to 12 month
Peripheral IFN-gamma concentration in the blood
Time frame: up to 12 month
Peripheral IP-10 concentration in the blood
Time frame: up to 12 month
Overall response rate of efti in combination with weekly paclitaxel both given the same day
Time frame: up to 12 month
Median progression free survival of efti in combination with weekly paclitaxel both given the same day
Time frame: up to 20 month
Median overall survival of efti in combination with weekly paclitaxel both given the same day
Time frame: up to 20 month
To characterise immunogenic properties of efti in combination with weekly paclitaxel both given the same day
Time frame: up to 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eftilagimod Alpha and Paclitaxel in people with Metastatic Breast Cancer, run by Immutep S.A.S..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day (time frame: up to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.