Lixte Biotechnology Holdings, Inc. has expanded its collaboration with The University of Texas MD Anderson Cancer Center and pharmaceutical manufacturer GSK on an ongoing clinical trial evaluating its proprietary compound LB-100 in combination with GSK's Dostarlimab for the treatment of ovarian clear cell cancer. The trial, initiated in January 2024 and led by Amir Jazaeri, MD, at MD Anderson, has added a second site at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University under the direction of Emily M. Hinchcliff, MD, MPH, and is expected to double enrollment to 42 patients following completion of its initial 21-patient target.
The expansion of this clinical trial represents a significant development in cancer research, particularly for ovarian clear cell carcinoma, which has historically shown limited response to conventional therapies. By doubling the patient enrollment and adding a prestigious second research site, the trial gains increased statistical power and geographic diversity, potentially accelerating the validation of this novel treatment approach. The company expects data from the initial cohort to be presented in the first half of 2026, providing crucial insights into the safety and efficacy of this combination therapy.
This trial expansion matters because ovarian clear cell cancer represents a particularly challenging subtype of ovarian cancer with poorer outcomes compared to other ovarian cancer types. The combination of Lixte's LB-100, a first-in-class PP2A inhibitor, with GSK's Dostarlimab represents an innovative approach that could potentially improve treatment outcomes for patients who have limited therapeutic options. The trial's expansion suggests promising early indicators that warrant further investigation across multiple research institutions.
The implications of this announcement extend beyond the immediate trial parameters. Successful results could establish a new treatment paradigm in oncology, demonstrating the potential of combining targeted therapies with immunotherapies. For patients with ovarian clear cell cancer, this represents hope for more effective treatment options. For the pharmaceutical industry, it validates the approach of combining novel mechanisms of action with established immunotherapies. The broader cancer research community will be watching these developments closely, as positive outcomes could influence treatment approaches for other cancer types as well.
LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data available at https://www.lixte.com, LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer. LIXTE's lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm. Proof-of-concept clinical trials are currently in progress for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer.
The expansion of this trial represents a critical step in translating preclinical research into potential clinical benefits for patients. By involving multiple leading cancer centers and increasing patient enrollment, the research gains both scientific rigor and practical relevance. The collaboration between a biotechnology company, academic medical centers, and a major pharmaceutical manufacturer exemplifies the type of partnership needed to advance cancer treatment. Additional information about LIXTE can be found at https://lixte.com/.
