AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase III Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization

Study Identifier:
IMP321-P016 (AIPAC-003)
CT.gov Identifier:
NCT05747794
EudraCT Identifier:
202200000000
EU Trial (CTIS) Number:
2024-511023-34-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To evaluate IMP321 in patients with metastatic breast cancer. To determine the optimal biological dose consistent with the FDA’s Project Optimus initiative.

To evaluate efti in combination with chemotherapy in hormone receptor positive (HR+), HER2-negative/low metastatic breast cancer resistant to endocrine-based therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy.

Main objective

DOSE OPTIMIZATION LEAD-IN: -To evaluate the safety and tolerability of 90 mg efti combined with paclitaxel, compared to 30 mg. -To define the optimal biological dose (OBD) of efti in combination with weekly paclitaxel for Phase 3 part of the trial. PHASE 3: -To demonstrate that OS is superior in patients treated with efti combined with weekly paclitaxel compared to weekly paclitaxel plus placebo.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II/III
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel eftilagimod alpha 30mg s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Biological: eftilagimod alpha APC activator, MHC II agonist Drug: Paclitaxel paclitaxel will be given as standard of care (chemotherapy) Patients have been randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha (efti”) in combination with paclitaxel. Experimental: open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel eftilagimod alpha 90mg s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Biological: eftilagimod alpha APC activator, MHC II agonist Drug: Paclitaxel paclitaxel will be given as standard of care (chemotherapy) Experimental: Phase 3: eftilagimod alpha + paclitaxel eftilagimod alpha s.c. (OBD) + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Biological: eftilagimod alpha APC activator, MHC II agonist Drug: Paclitaxel paclitaxel will be given as standard of care (chemotherapy) Placebo Comparator: Phase 3: placebo + paclitaxel placebo s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Drug: Paclitaxel paclitaxel will be given as standard of care (chemotherapy) Other: placebo placebo matching eftilagimod alpha ASCO 2023: Pts will receive paclitaxel (80 mg/m2 I.V. on D1, 8 and 15 in a 4-week cycle), followed by efti or placebo (DOL: 30 or 90 mg efti; Phase 3: OBD of efti or placebo) S.C. on D1 and 15 in a 4-week cycle for up to 12 months. Phase II: patients who will receive 30mg efti or 90mg efti ASCO 2024 pts will be randomized to receive either paclitaxel + efti or paclitaxel + placebo in a double-blinded fashion. ...Pts will receive paclitaxel (80 mg/m2 I.V. on D1, 8 and 15 in a 4-week cycle), followed by efti or placebo (DOL: 30 or 90 mg efti; Phase 3: OBD of efti or placebo) S.C. on D1 and 15 in a 4-week cycle for up to 12 months. Imaging is done every 8 weeks and assessed by the investigator. in the DOL blood samples are taken from 0 to 96 hours in cycle 1 and 4 to determine PK / PD profiles. PK / PD parameters are assessed by a central lab.
Study Status
Indicates the current recruitment status or the expanded access status
Study Complete

Requirements information
Inclusion criteria
  • Pts with either a) HR+ and HER2-neg/low and endocrine therapy-resistant MBC or b) TNBC not eligible for anti-PD-1-based therapy. Pts must have measurable disease, ECOG PS 0-1 and no prior chemotherapy for metastatic disease.
  • Exclusion Criteria:
  • Prior chemotherapy for metastatic breast adenocarcinoma
  • Participants with HR+ MBC who have received <1 line of ET based therapy in the metastatic setting
  • Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
  • TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
  • Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
Exclusion criteria
  • Pts if HR+ who are not considered endocrine resistant and/or have received < 1 line of therapy in the metastatic setting. Pts who are considered TNBC and are eligible for anti-PD-(L)1 containing therapy.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Bernard Doger de Speville
Status
Recruitment Complete
Condition(s) Treated at Site
Breast Cancers