This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.
Has a tumor with a confirmed MTAP loss
Is ≥18 years of age at the time of signature of the main study ICF
Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate.
Is able to swallow tablets
A female patient is who is pregnant or breastfeeding
Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)
Has an active infection requiring systemic therapy
Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
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Treatment groupsSee each treatment group below.
Tango Therapeutics, Inc.
Lead sponsor
Eli Lilly and Company
Collaborator