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Poster display session

1996 - A first-in-human, open-label, multicenter Phase 1/2a study to evaluate the safety and efficacy of increased repeated doses of the first in class RORγ agonist LYC-55716 in treating locally advanced or metastatic solid tumors


10 Sep 2017


Poster display session


Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Immunotherapy


H Wilkins


Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376


H.J. Wilkins1, E.P. Hamilton2, D. Mahalingam3

Author affiliations

  • 1 Clinical Development, Lycera Corp., 19462 - Plymouth Meeting/US
  • 2 Breast Cancer And Gynecologic Cancer Research Program, Sarah Cannon Research Institute/Tennessee Oncology, Nashville/US
  • 3 Medical Oncology, University of Texas Health Science Center San Antonio, San Antonio/US


Abstract 1996


LYC-55716, a first-in-class oral, small-molecule agonist of nuclear receptor retinoic acid–related orphan receptor γ (RORγ), has been shown in preclinical models to modulate gene expression to reprogram immune cell antitumor effector function and decrease immunosuppressive mechanisms, resulting in immune-mediated tumor growth control and enhanced survival. Data suggest that LYC-55716 acts via well-known antitumor mechanisms by increasing immune cell trafficking and recruitment to tumors, enhancing T cell effector function and memory development, and promoting T cell survival. LYC-55716 may enhance immune-mediated antitumor responses via its effects on T effector/Treg cell ratios, PD-1 expression, and sensitivity to PD-L1 inhibition of T cell proliferation. A first-in-human, single-arm, open-label multicenter Phase 1/2a study is ongoing to evaluate the safety and tolerability of LYC-55716 and determine the maximum tolerated dose and objective response rate. All adult subjects enrolled will have relapsed or refractory metastatic cancer and have failed to responded to standard therapies.

Trial design

The Phase 1 portion of the study will follow a dose-escalation design to evaluate the occurrence of dose-limiting toxicities (DLTs) and determine the maximum tolerated dose and recommended Phase 2 dose of LYC-55716. Following a screening period, adults with locally advanced or metastatic solid tumors will receive 28-day treatment cycles of LYC-55716 BID (n = 4–6/cohort). Dosing escalation considers dose and dosing regimen and is determined by PK profile and safety. Primary endpoints include safety (monitoring of adverse events, physical examination, and lab results) and incidence of DLTs (Grade 3 or 4 toxicities) during the first 28-day treatment cycle. Secondary endpoints include objective tumor response rate as assessed via response evaluation criteria in solid tumors (RECIST) v1.1 assessed at scans performed every 8 weeks, pharmacokinetics, and pharmacodynamics. Results for the first three cohorts of the Phase 1 portion of the study will be available at the time of presentation.

Clinical trial identification


Legal entity responsible for the study

Lycera Corp.


Lycera Corp.


H.J. Wilkins: Employee and shareholder of Lycera Corp. All other authors have declared no conflicts of interest.

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