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IMP321 · 5 trials · 6 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 |
| B | EXPERIMENTAL | - |
| 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. |
| saline | BIOLOGICAL | saline injected alone in step 1 or mixed with Aggripal in step 2 |
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 is an investigational monoclonal antibody being studied in oncology. It has been evaluated in clinical trials for metastatic breast cancer, stage IV renal cell carcinoma, stage IV melanoma, and as an adjuvant in healthy volunteers. It is not approved and remains in clinical development.
IMP321 is being developed by Immutep Limited, a biopharmaceutical company listed on the stock exchange under the ticker IMMP. The company has sponsored clinical trials of IMP321 in various cancer indications.
IMP321 is in Phase 2 clinical development. It has completed Phase 1 trials in metastatic breast cancer, metastatic renal cell carcinoma, melanoma, and healthy volunteers. The drug is investigational and not yet approved by regulatory authorities.
IMP321 has been studied in several completed clinical trials, including NCT00349934 in metastatic breast cancer, NCT00351949 in stage IV renal cell carcinoma, NCT00354263 in healthy volunteers, and NCT02676869 in stage IV melanoma. These trials were Phase 1 studies.
Yes, IMP321 is also known as eftilagimod alpha. One clinical trial, NCT02676869, refers to IMP321 as eftilagimod alpha in its title. This alternative name is used in research publications and trial registries.
IMP321 is a monoclonal antibody that targets the LAG-3 protein, a molecule involved in regulating immune responses. By binding to LAG-3, it aims to modulate the immune system's activity against cancer cells. This mechanism is being explored in oncology clinical trials.