|The following article features coverage from the European Society of Medical Oncology (ESMO) Congress 2021. Click here to read more of Hematology Advisor’s conference coverage.|
GZ17-6.02, a novel anticancer drug derived from botanical molecules, appears to show clinical activity across a wide range of malignancies, according to research presented at the European Society for Medical Oncology 2021 Congress.
Previous research suggests that extracts from some botanicals may yield anticancer effects. Curcumin, for example, has been studied as a potential anticancer drug, and a combination of isovanillin, harmine, and curcumin has shown promise in the preclinical setting.
For this multicenter phase 1 study (ClinicalTrials.gov Identifier: NCT03775525), researchers evaluated the safety, activity, and pharmacokinetics of GZ17-6.02, an optimized ratio of isovanillin, harmine, and curcumin, among patients with solid tumors or lymphoma. All patients received oral GZ17-6.02 daily for 28 days, with dose escalation following a standard 3+3 design.
At the time of study presentation, 36 patients had enrolled, including 24 in the study’s dose escalation phase and 12 in the dose expansion phase. The recommended phase 2 dose was 375 mg twice daily.
Overall, the study’s investigators determined that 7 patients benefited clinically from GZ17-6.02, including 1 partial response in a patient with EGFR-mutant non-small cell lung cancer; 6 patients had stable disease.
Of 32 evaluable patients, grade 3 to 4 transaminitis was noted in 6 patients, and was reversible on drug discontinuation. Three of these cases occurred at doses higher than the recommended phase 2 dose.
“GZ17-6.02 was biologically active and demonstrated an acceptable and manageable safety profile in a heavily pretreated patient population with various malignancies,” the authors wrote. “This phase 1 data provides rational for further investigation in a phase 2 setting to determine GZ17-6.02’s safety and potential efficacy in defined patient populations, both as monotherapy and in combination with other therapeutics.”
Disclosure: Some [or one] study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Mita A, Mita M, Tsai F, Moore RP, Bailes J, Matrana M. Phase I study of oral GZ17-6.02 in patients with advanced solid tumors or lymphoma. Presented at: European Society of Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract 548P.