Integrative Cancer Therapies · Published 2026-02-01 · DOI 10.1177/15347354251410182
Background: Withania somnifera (WS), commonly known as ashwagandha, has been used in the traditional medical system of India. It has shown significant activity against numerous solid tumor varieties in pre-clinical in vitro and in vivo studies. This study focuses on RH324 (ReHeva Biosciences, Columbus, OH), a pharmaceutical-grade formulation derived from WS, which has received FDA allowance for clinical development as a botanical drug in the treatment of cancer. Methods: A phase 1 open label dose ranging study of oral RH324 in advanced non-small cell lung cancer (NSCLC) was conducted. The primary endpoint of the study was assessment of short-term safety and tolerability. An exploratory aim was assessment of RH324’s anti-neoplastic effects as measured by changes in tumor metabolism using [ 18 F]-labeled 2-fluoro-2-deoxy-D-glucose (FDG)-PET/CT scans performed before and after completing a 28-day RH324 monotherapy regimen. A total of 9 patients were enrolled, 5 of which completed the trial, including imaging, and were evaluable. Results: All study safety and tolerability primary endpoints were met. Analysis revealed notable response rates across different SUV parameters (SUV max , SUV mean , and SUV peak ) and there were no new metastatic lesions identified, further supporting RH324’s anti-neoplastic effects. Conclusion: RH324 was safe and well tolerated as a monotherapy in advanced NSCLC. FDG-PET/CT provided a novel methodology as a short-term metabolic endpoint with an in vivo biomarker assessment of potential clinical efficacy using a metabolic surrogate of disease activity. This approach offered deeper insights into tumor metabolism and heterogeneity, underscoring the potential of RH324’s anti-neoplastic effects in treating refractory NSCLC. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT05580172, Registered on October 17, 2022.
Abstract from DOAJ. Public domain (CC0 1.0).
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