LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) has initiated a pivotal Phase 1b/2 clinical trial, in partnership with GSK, to evaluate the potential of combining LIXTE’s LB-100 with GSK’s PD-1-blocking antibody, dostarlimab-gxly, in treating ovarian clear cell carcinoma (OCCC).

The University of Texas MD Anderson Cancer Center is conducting this trial, with LIXTE providing LB-100 and GSK contributing dostarlimab-gxly and financial support. This trial (NCT06065462) explores the hypothesis by lead investigator Amir Jazaeri, MD, that reducing PP2A pharmacologically may enhance sensitivity to immunotherapy, potentially improving treatment efficacy for OCCC patients.

The primary objective of this study is to estimate overall survival in patients with recurrent ovarian clear cell carcinoma treated with LB-100 and dostarlimab. Secondary objectives include assessing clinically significant adverse events, determining the objective response rate, progression-free survival, and duration of response. Additionally, translational research will focus on PP2A activity, immune changes, and expression of mismatch repair proteins, correlating these factors with treatment response.

This trial marks a significant advancement in cancer treatment, particularly in ovarian clear cell carcinoma, a challenging cancer subtype to treat. By combining LB-100 and dostarlimab-gxly, the study aims to enhance the anti-tumor effect and provide a potential therapeutic benefit for patients.

LIXTE and GSK’s collaboration in this clinical trial represents a crucial step in advancing cancer treatment options. This innovative approach to combining therapies could open new avenues for treating ovarian cancer and potentially other cancer types, offering hope to countless patients worldwide.

The launch of this Phase 1b/2 clinical trial by LIXTE Biotechnology, in collaboration with GSK, is a noteworthy development in the field of oncology. It underscores the importance of innovative therapeutic strategies in tackling hard-to-treat cancers like OCCC. The trial’s focus on pharmacologically targeting PP2A to enhance immunotherapy’s effectiveness may pave the way for breakthroughs in cancer treatment.

  dostarlimab-gxly, GSK, LB-100, LIXTE Biotechnology, Ovarian Cancer, University of Texas MD Anderson Cancer Center