Due 1/12/26 - Solicitation for Submission of Pre-LOIs for Golcadomide
December 19, 2025
As part of the golcadomide (GOLCA; CC-99282) clinical development program, CTEP would like to request pre-solicitation applications from all interested UM1 investigators for selected studies.
Golcadomide is a potential first-in-class oral cereblon-modulating agent for the treatment of patients with Non-Hodgkin Lymphomas (NHL). Similar to immunomodulatory drugs (IMiDs) such as lenalidomide, golcadomide co-opts the CRL4CRBN E3 ubiquitin ligase component cereblon and enhances the binding, ubiquitination, and proteasomal degradation of zinc finger transcription factors ikaros (IKZF1) and aiolos (IKZF3) (Thakurta et al., 2021. Oncotarget. 12(15):1555-1563). Preclinical NHL studies using golcadomide have demonstrated origin-independent antiproliferative activity and potent (10-100-fold compared to other IMiD and CELMoD agents) pro-apoptotic activity. These effects included derepression of cyclin dependent kinase (CDK) inhibitors, induction of interferon (IFN)-inducible genes, and suppression of oncogenic factors such as c-Myc and IRF4. Furthermore, golcadomide administration resulted in significant target tissue distribution, including blood-brain barrier penetration, and anti-tumor activity in mouse lymphoma xenograft models. Golcadomide additionally demonstrated immunomodulatory effects by inducing IL-2 secretion in T-cells, resulting in the production of anti-tumor effector cytokines. Combination treatment using golcadomide and the CD20-targeted antibody rituximab demonstrated enhanced cell-killing and tumor growth inhibition capabilities (Lopez-Girona et al., 2021. Hematol Oncol. 39(supplement 2):315-316; Carrancio et al., 2021. Blood. 138(supplement 1):1200-1201).
For more information please see the Full Announcement of Pre-Solicitation:
Solicitation for Submission of Pre-LOIs for Golcadomide
If you are interested in conducting a trial with golcadomide in (any of) the above-described setting(s), please coordinate with Dr. Geoffrey Shapiro (geoffrey_shapiro@dfci.harvard.edu) and fill out the above Pre-LOI form. Final Submissions to CTEP must be made by COB January 12, 2026.
Please note that in the case of an ECI application, the ECI-PI’s curriculum vitae and letters of mentorship and institutional commitment must be submitted together with the Pre-LOI application via e-mail. The Investigational Drug Branch will review the submissions and make a formal request for a full LOI on or around February 9, 2026.
Should you have questions or concerns regarding this process or the solicited golcadomide trials, please contact Dr. Lorraine Pelosof at 240-276-6281 or lorraine.pelosof@nih.gov and CC Dr. Shapiro on your communications.