23ME-00610 for Cancer

Recruiting at 14 trial locations

Overseen By Study Inquiry

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: 23andMe, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Pregnancy, Autoimmune disease, Transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

141 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first-in-human open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-00610 given by intravenous infusion in patients with advanced solid malignancies who have progressed on all available standard therapies

Eligibility Criteria

This trial is for adults and adolescents with various advanced solid cancers that have worsened despite all standard treatments. Specific conditions include certain neuroendocrine, ovarian, renal cell, and small cell lung cancers. Participants must be in relatively good physical condition with a life expectancy of at least 12 weeks.

Inclusion Criteria

I have at least one tumor that can be measured and hasn't been treated with radiation.

My ovarian, fallopian tube, or peritoneal cancer is advanced, cannot be surgically removed, and has not responded to platinum-based treatment.

You have advanced kidney or ovarian cancer that has not responded to standard treatments, or there are no more standard treatment options available for you.

Exclusion Criteria

I have had hepatitis C or B, or HIV, but it's either treated or undetectable.

I have an autoimmune disease treated with strong medication in the last 2 years.

I do not have uncontrolled brain metastases or meningitis from cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Patients will receive escalating doses of 23ME-00610 to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

8-12 weeks

Monotherapy Expansion

Patients will receive the recommended dose(s) of 23ME-00610 in tumor-specific cohorts to further evaluate safety, tolerability, and clinical activity

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• 23ME-00610

Trial Overview The study tests the safety and effectiveness of a new drug called 23ME-00610 administered via IV to patients with advanced solid tumors who've exhausted standard therapies. It's an early-phase trial assessing how the body processes the drug and its preliminary effects on cancer.

Participant Groups

Group I: Part B Experimental Treatment 1 Intervention

Patients will receive the recommended dose(s) of 23ME-00610

Group II: Part A Experimental Treatment 1 Intervention

Patients will receive escalating doses of 23ME-00610

Who Is Running the Clinical Trial?

23andMe, Inc.

Lead Sponsor

Trials

10

Recruited

83,700+