23ME-00610 for Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 23ME-00610, an experimental drug for individuals with advanced solid cancers that haven't responded to standard treatments. The research is in its early stages to assess the drug's safety and effectiveness, with patients receiving it through an IV drip. The trial consists of two parts: one explores different doses, and the other tests a recommended dose to evaluate its efficacy. Individuals with cancers such as kidney cancer, ovarian cancer, or certain neuroendocrine tumors, which have worsened despite other treatments, might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had certain cancer treatments like chemotherapy or immunotherapy within 4 weeks before starting the trial.

Is there any evidence suggesting that 23ME-00610 is likely to be safe for humans?

Research has shown that 23ME-00610 is generally safe for patients with advanced cancer. Studies have found that side effects are usually mild to moderate, indicating they are not very serious. Administering the treatment every three weeks aligns well with how the body processes the drug. Overall, the safety data suggests that patients tolerate 23ME-00610 well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 23ME-00610 for cancer because it targets the condition differently from existing treatments like chemotherapy, radiation, and targeted therapies. 23ME-00610 is designed to work by modulating the immune system, potentially enhancing the body's natural ability to fight cancer cells. This novel approach could offer an alternative for patients who may not respond well to conventional therapies. Additionally, early trials explore different dosing strategies to optimize its effectiveness and safety, potentially leading to more personalized cancer treatment options.

What evidence suggests that 23ME-00610 might be an effective treatment for cancer?

Research has shown that 23ME-00610 holds promise for treating advanced solid tumors. Patients generally tolerate it well, and it is considered safe. The drug targets a specific protein that aids tumor growth. Early study results suggest potential benefits, particularly for clear-cell renal-cell carcinoma, where some patients have shown improvement. Although results for ovarian cancer have been modest, ongoing research remains encouraging. In this trial, participants will receive 23ME-00610 every three weeks. Part A involves escalating doses, while Part B uses the recommended dose(s), which effectively engages its target. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11734590/

First-in-Human Study of 23ME-00610, an Antagonistic ... 23ME-00610 has mild-to-moderate on-target AEs and PK/PD consistent with tumor target saturation and dosing every 3 weeks. The trend for clinical ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5575

Safety, efficacy, and PKPD of 23ME-00610, a first-in-class ... 23ME-00610 continues to show encouraging PKPD and acceptable safety, but only modest disease control in unselected advanced ovarian cancer patients.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02206-3/fulltext

620P Efficacy, safety and PKPD of 23ME-00610, a first-in- ... 23ME-00610 continues to show acceptable safety and tolerability, full peripheral target engagement, and PK that supports Q3W dosing, though limited anti-tumor ...

4. aacrjournals.org aacrjournals.org/cancerres/article/83/8_Supplement/CT174/725184/Abstract-CT174-First-in-class-anti-CD200R1

First-in-class anti-CD200R1 antibody 23ME-00610 in patients ... Conclusion: 23ME-00610 demonstrated an acceptable safety and tolerability profile, with favorable PK and peripheral CD200R1 saturation.

5. mediacenter.23andme.com mediacenter.23andme.com/press-releases/23andme-therapeutics-announces-phase-2-results-two-additional/

23andMe Therapeutics Announces Phase 2 Results for ... 23ME-00610 monotherapy demonstrates preliminary evidence of clinical benefit in clear-cell renal-cell carcinoma, with one confirmed partial ...

6. investors.23andme.com investors.23andme.com/node/9046/pdf

23andMe Announces Updated Safety and Preliminary Efficacy ... Preliminary PK data support dosing 23ME-00610 every three weeks (Q3W). 23ME-00610 has a favorable PK and PD profile, with median half-life of.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05199272

NCT05199272 | A Phase 1/2a Study of 23ME-00610 in ... This is a first-in-human open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical ...