Study Summary
This trial is testing a new drug for safety and how well it works in patients with cancer who have already tried other treatments.
Eligible Conditions
- Solid Tumors
- Primary Peritoneal Carcinoma
- Small Cell Lung Cancer
- Microsatellite Instability-High Cancer
- Clear Cell Renal Cell Carcinoma
- Ovarian Cancer
- High Tumor Mutational Burden Cancer
- Neuroendocrine Tumors
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
9 Primary · 30 Secondary · Reporting Duration: Up to 5 years
21 days
Part A: Incidence and severity of dose-limiting toxicities (DLTs)
Part B adolescents: Incidence and severity of dose-limiting toxicities (DLTs)
Day 21
Part A: Terminal half-life (T1/2) following a single dose of 23ME-00610
Terminal half-life (T1/2) following a single dose of 23ME-00610
Day 21
Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-00610
Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-00610
Last measurable serum concentration (Clast) following a single dose of 23ME-00610
Maximum serum concentration (Cmax) following a single dose of 23ME-00610
Part A: Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-00610
Part A: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-00610
Part A: Last measurable serum concentration (Clast) following a single dose of 23ME-00610
Part A: Time of maximum serum concentration (Tmax) following a single dose of 23ME-00610
Part A:Maximum serum concentration (Cmax) following a single dose of 23ME-00610
Time of maximum serum concentration (Tmax) following a single dose of 23ME-00610
Day 21
Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-00610
Maximum serum concentration (Cmax) following multiple doses of 23ME-00610
Part A: Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-00610
Part A: Maximum serum concentration (Cmax) following multiple doses of 23ME-00610
Part A: Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-00610
Part A: Terminal half-life (T1/2) following multiple doses of 23ME-00610
Part A: Time of maximum serum concentration (Tmax) following multiple doses of 23ME-00610
Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-00610
Terminal half-life (T1/2) following multiple doses of 23ME-00610
Time of maximum serum concentration (Tmax) following multiple doses of 23ME-00610
Year 5
Part A: Objective response rate (ORR)
Part B: Objective response rate (ORR)
Day 5
Part A: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-00610
Prevalence and incidence of antidrug antibodies (ADA) to 23ME-00610
Up to 5 years
Disease Control Rate (DCR)
Duration of response (DoR)
Overall survival (OS)
Progression free survival (PFS)
Day 90
Part A: Incidence and severity of adverse events (AEs)
Part A: Incidence and severity of serious adverse events (SAEs)
Part A: Incidence of withdrawals due to AEs
Part B adolescents: Incidence and severity of adverse events (AEs)
Part B adolescents: Incidence and severity of serious adverse events (SAEs)
Part B adolescents: Incidence of withdrawals due to AEs
Week 6
Part B: Assessment of changes to target cell enumeration and/or phenotype by IHC and/or RNA
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Part A
1 of 2
Part B
1 of 2
Experimental Treatment
140 Total Participants · 2 Treatment Groups
Primary Treatment: 23ME-00610 · No Placebo Group · Phase 1 & 2
Part A
Drug
Experimental Group · 1 Intervention: 23ME-00610 · Intervention Types: DrugPart B
Drug
Experimental Group · 1 Intervention: 23ME-00610 · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
23andMe, Inc.Lead Sponsor
7 Previous Clinical Trials
83,582 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:For Part B, Cohort 1B: You have advanced kidney cancer that cannot be removed by surgery or has spread to other parts of the body and has not responded to standard treatments. For Cohort 2B: You have advanced ovarian, fallopian tube, or peritoneal cancer that has come back within 6 months of completing platinum-based therapy and has not responded to standard treatments.
- Cohort 5B: Teenagers with advanced or metastatic cancer that has not responded to standard treatments or for which no other standard treatment exists.
- Cohort 6B: People with a specific type of advanced or metastatic cancer that has not responded to standard treatments or for which no other standard treatment exists.
- Part A: Adults with a good ability to perform daily activities and a life expectancy of at least 12 weeks, and who have cancer that is not measurable by standard methods.
- Part B: Teenagers and adults with a good ability to perform daily activities and a life expectancy of at least 12 weeks, and who have measurable cancer that has not been treated with radiation.
You have a specific type of neuroendocrine cancer that has not responded to standard treatments or there are no more standard treatments available. This includes Merkel cell carcinoma, certain well-differentiated Grade 3 neuroendocrine cancers, and poorly differentiated neuroendocrine carcinoma. If you have another type of cancer with some neuroendocrine features, you may be considered for the study with approval from the medical monitor.
Who else is applying?
What state do they live in?
| Michigan | 100.0% |
What site did they apply to?
| Karmanos Cancer Institute | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "I'm getting treatment with Keytruda every three weeks. I have endometrial cancer mets to my abdomen and pelvic area, stage4."
Frequently Asked Questions
Are there any vacancies for participants in this research endeavor?
"According to information hosted on clinicaltrials.gov, this medical experiment is actively recruiting patients and has been since it was first posted in December 2021 with the most recent update coming November 2022." - Anonymous Online Contributor
Unverified Answer
Could you kindly provide the overall count of participants involved in this clinical trial?
"To fulfill the requirements of this medical experiment, 105 people who meet all necessary selection criteria are needed. Patients can be recruited from Princess Margaret Cancer Centre in Toronto, Texas and Oregon's Investigational Site located in San Antonio." - Anonymous Online Contributor
Unverified Answer
What potential hazards can be associated with 23ME-00610?
"Due to the limited data regarding 23ME-00610's efficacy and safety, our team at Power rated it a 1 on its scale of 1 to 3." - Anonymous Online Contributor
Unverified Answer
Are there numerous sites in the U.S. conducting this medical trial?
"This study is currently being conducted in 6 different sites, including Toronto, San Antonio and Houston. To reduce travel demands if you decide to take part, it's recommended that you choose the closest location near you." - Anonymous Online Contributor
Unverified Answer