AIPAC Active Immunotherapy PAClitaxel
Active Immunotherapy PAClitaxel (AIPAC) is a Phase II b trial in metastatic breast cancer (MBC).
The multinational, randomized, double-blind, placebo-controlled Phase IIb study of IMP321 is conducted in Europe with more than 200 patients.
IMP321 is tested in combination with a taxane called paclitaxel based chemotherapy in hormone receptor positive metastatic breast cancer patients.
The safety-run in phase with 15 patients has been completed successfully showing IMP321 as safe and well tolerated. The randomized phase is following with 226 patients in two arms with 113 patients each and an application of paclitaxel+IMP321 and paclitaxel+placebo respectively. It is planned to conduct the study in more than 30 clinical sites in more than 5 countries.
Please visit clinicaltrials.gov for further information about the study (clinicaltrials.gov identifier NCT 02614833).
TACTI-mel Two ACTive Immunotherapeutics in melanoma
Two ACTive Immunotherapeutics in melanoma is a safety and dose finding IMP321 study.
The clinical Phase I study is a combinatorial setting with IMP321 and a PD-1 checkpoint inhibitor called Keytruda.
TACTI-mel is planned to enroll up to 18 patients with locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma with ascending subcutaneous doses of IMP321 up to 30 mg per injection.
Safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of IMP321 at the various doses as well as the nature of the immune response in the combination will be evaluated. The primary endpoint will be safety and tolerability.
Please visit clinicaltrials.gov for further information about the study (clinicaltrials.gov identifier NCT 02676869).