23ME-00610 Clinical
Trial Information

Clinical trials are research conducted in people that test medical or behavioral interventions. This includes studying if new treatments are safe and effective in people. Clinical trials are reviewed by Institutional Review or Ethics Boards and comply with local and international guidelines and regulations. Any new treatment must meet specific goals at every phase of a clinical trial, including evaluating if there are side effects, identifying an optimal dose and schedule, and testing if the treatment is more effective than the standard of care treatments.

Learn more about our clinical trial

Study 23ME-00610-CLIN-001 is a Phase 1/2a clinical trial that includes 2 parts. The first portion of the trial is a dose-escalation phase to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of 23ME-00610 in patients with locally advanced (unresectable) or metastatic solid malignancies who have progressed on all available standard therapies. The second portion of the trial is the expansion phase to evaluate the monotherapy anticancer activity of 23ME-00610 and further evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of 23ME-00610 in patients with the following locally advanced (unresectable) or metastatic solid malignancies: clear cell renal cell carcinoma (ccRCC), epithelial ovarian, fallopian tube or primary peritoneal carcinoma, neuroendocrine cancers, microsatellite instability-high (MSI-H) and/or tumor mutational burden-high (TMB-H) solid cancers, extensive stage small cell lung cancer (ES-SCLC) and adolescents with locally advanced (unresectable), or metastatic solid cancers.

23ME-00610 is being studied in patients with locally advanced (unresectable) or metastatic solid malignancies who have progressed on all available standard therapies in the Phase 1 portion of the trial. In the Phase 2a portion, 23ME-00610 is being evaluated in patients with the following solid malignancies that have progressed after all available standard therapies: clear cell renal cell carcinoma (ccRCC), epithelial ovarian, fallopian tube or primary peritoneal carcinoma, neuroendocrine cancers, microsatellite instability-high (MSI-H) and/or tumor mutational burden-high (TMB-H) solid cancers, extensive stage small cell lung cancer (ES-SCLC) and adolescents with locally advanced (unresectable), or metastatic solid cancers.

You may be eligible for the expansion phase of the trial if you are an adult or adolescent greater than or equal to 12 years of age with one of the following solid malignancies that has progressed after all available standard therapies: clear cell renal cell carcinoma (ccRCC), epithelial ovarian, fallopian tube or primary peritoneal carcinoma, neuroendocrine cancers, microsatellite instability-high (MSI-H) and/or tumor mutational burden-high (TMB-H) solid cancers, extensive stage small cell lung cancer (ES-SCLC) or adolescents with locally advanced (unresectable), or metastatic solid cancers.

Please refer to ClinicalTrials.gov for additional eligibility criteria.

To learn more about this study, you or your doctor may contact the study research staff: Phone: Study Inquiry (650) 963-8997

Email: studyinquiry@23andme.com

The primary objectives of the dose-escalation phase are safety, tolerability and determination of the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of 23ME-00610. The primary objective of the expansion phase is evaluation of the monotherapy anticancer activity of 23ME-00610.

Please refer to ClinicalTrials.gov for additional study objectives.