Chemo-Immunotherapy for Breast Cancer
(AIPAC-003 Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Immutep S.A.S.

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy? * Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone? In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled). The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.

Eligibility Criteria

This trial is for individuals with metastatic breast cancer who are set to receive paclitaxel chemotherapy. It's open to those with triple-negative breast cancer not getting PD-1/PD-L1 therapy, or hormone receptor-positive patients after at least one endocrine therapy. Participants should be in good physical condition (ECOG 0-1) and expected to live more than three months.

Inclusion Criteria

I have triple-negative breast cancer and am to receive paclitaxel without PD 1/PD-L1 therapy for metastatic disease.

My HR+ breast cancer has worsened after endocrine therapy, and I need chemotherapy.

My breast cancer is either hormone receptor positive or negative, and HER2 negative.

+2 more

Exclusion Criteria

My cancer returned less than a year after my last chemotherapy.

My breast cancer responds to hormone therapy and I am eligible for such treatment.

I have HR+ metastatic breast cancer and received less than one line of hormone therapy.

+2 more

Participant Groups

Researchers are testing eftilagimod alpha (efti), an immunotherapy drug, combined with standard paclitaxel chemotherapy against placebo plus chemotherapy. They aim to find the best dose of efti and see if it improves survival rates compared to chemotherapy alone in two phases: chemo-immunotherapy followed by immunotherapy.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxelExperimental Treatment2 Interventions

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.

Group II: open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxelExperimental Treatment2 Interventions

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.

Group III: Phase 3: eftilagimod alpha + paclitaxelExperimental Treatment2 Interventions

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.

Group IV: Phase 3: placebo + paclitaxelPlacebo Group2 Interventions

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.