This study is for subjects that have been diagnosed with advanced solid cancer tumors or relapsed prostate cancer. The investigational drugs in this study are hydroxychloroquine, nelfinavir, metformin, dasatinib and sirolimus. The purpose of this study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of cancer. Subjects can expect to be in this study for about 2.5 years.
This is a 2 Part, Phase 3, open-label, randomized study to sequentially demonstrate the pharmacokinetic noninferiority of amivantamab SC-CF administered via manual injection compared with amivantamab IV (Part 1) and the bioequivalence of amivantamab SC-CF administered via a manual injection versus amivantamab subcutaneous, co-formulated with recombinant human hyaluronidase, and delivered with an on-body delivery system (SC-CF OBDS; Part 2). The combination product of the device (on-body delivery system; OBDS) plus the study drug amivantamab SC-CF (hereafter referred to as amivantamab SC-CF OBDS) is provided as a completely assembled, ready to use, single-use product. It is preloaded with a prefilled liquid drug product vial, thereby eliminating the need for drug preparation by a pharmacist. The formulation of amivantamab SC-CF used in amivantamab SC-CF OBDS is identical to the manual injection formulation of amivantamab SC-CF (but differs from the IV formulation).
Lazertinib (JNJ-73841937) is an oral, highly potent, third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) with no demonstrated pharmacokinetic (PK) interaction with amivantamab. It selectively inhibits both activating EGFR mutations (Exon 19del, L858R) and the EGFR T790M resistance mutation
while showing mutant-selective activity for EGFR.
The primary objectives are to assess the pharmacokinetic noninferiority of amivantamab SC-CF via manual injection versus amivantamab IV (Part 1) and to assess the bioequivalence of amivantamab SC-CF via manual injection and amivantamab SC-CF OBDS (Part 2). Key secondary objectives are to assess efficacy (objective response rate [ORR] and progression-free survival [PFS]) and safety of the different administrations.
This study is for subjects with endometrial cancer has spread to other parts of your body and/or has not responded to previous treatment(s). The study is being done to see if combining two immunotherapy drugs, nivolumab and ipilimumab, more effective in shrinking their cancer and preventing its growth than single drug immunotherapy with nivolumab alone. The subject can expect to be in this study for up to 24 months.