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Also known as IMP321 (eftilagimod alpha), LAG-3, hLAG-3Ig, CD223, eftilagimod alpha, efti, eftilagimod alfa, LAG-3Ig
IMP321 · 4 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Paclitaxel + IMP321 at the RPTD | EXPERIMENTAL | The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, either IMP321, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (IMP321) every 4 weeks during the maintenance phase for an additional period of up to 12 injections |
| Comparator: Paclitaxel + Placebo | ACTIVE_COMPARATOR | The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, placebo, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (placebo) every 4 weeks during the maintenance phase for an additional period of up to 12 injections |
| IMP321 dose escalation | EXPERIMENTAL | IMP321 administered fortnightly in addition to SOC pembrolizumab. |
| A | EXPERIMENTAL | IMP321 |
| Name | Type | Description |
|---|---|---|
| IMP321 (eftilagimod alpha) | BIOLOGICAL | In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo |
| Placebo | DRUG | In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD |
| Paclitaxel | DRUG | Paclitaxel will be given in both treatment arms (classified as Non IMP) |
| Pembrolizumab | DRUG | Administered according to the approved label. |
| IMP321 | BIOLOGICAL | This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle). Three IMP321 dose levels (250 µg, 1,250 µg and 6,250 µg) will be evaluated in three cohorts of 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 s.c. injections in total), separated by 13-day intervals free of IMP321 administration. The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy. |
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 ab...
IMP321 (eftilagimod alpha) is an investigational immunotherapy being studied in oncology. Its clinical trials have enrolled patients with Stage IV melanoma, metastatic breast cancer, and Stage IV renal cell carcinoma. It has been tested as an adjunct to standard chemotherapy and in combination with anti-PD-1 therapy. It is not approved for any indication.
IMP321 (eftilagimod alpha) targets LAG-3, a protein receptor on immune cells. It is a monoclonal antibody designed to bind LAG-3 and is being developed as an immunotherapy for solid tumors. By engaging this target, it is intended to support immune responses against cancer.
IMP321 (eftilagimod alpha) is being developed by Immutep Limited, which trades under the ticker IMMP. Immutep is the sponsor of the clinical trials evaluating the drug in melanoma, breast cancer, and renal cell carcinoma.
IMP321 (eftilagimod alpha) is in Phase 2 clinical development. It remains investigational and has not been approved by the FDA or any regulatory authority. The Phase 2 trial in metastatic breast carcinoma has been completed, and Phase 1 studies in melanoma and renal cell carcinoma have also been completed.
IMP321 (eftilagimod alpha) has been studied in four completed clinical trials. These include NCT02676869 in Stage IV melanoma, NCT02614833 in Stage IV breast adenocarcinoma, NCT00351949 in metastatic renal cell carcinoma, and NCT00349934 in metastatic breast carcinoma. All trials have finished, and no trials are currently active.
Yes, IMP321 and eftilagimod alpha are the same drug. IMP321 is the original code name, and eftilagimod alpha is the international nonproprietary name. Both refer to the LAG-3 targeting monoclonal antibody developed by Immutep Limited.