Clinical Trial: Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies (incl Neuroendocrine Neoplasms)

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Who are 23andMe?

I personally had not heard of 23andMe but many people in North America might have.  When you first look at what they do, you can be excused for thinking they are just another ‘Ancestry’ company, but they are more than that. They also get involved in genetics and health.  To quote their marketing “we’re all of these things”.  Read more here:  About us – 23andMe But what I found most interesting is that they have a clinical trial involving Neuroendocrine Tumors using their product 23ME-00610.  However, an analysis of the documentation available indicates it is aimed at Grade 3 both well and poorly differentiated.  Also includes small cell lung cancer (SCLC) and Merkel Cell Carcinoma

The results from this clinical trial were presented at a recent conference and I will be linking those below in ‘Further Reading’. 

…… read on. 

What is 23ME-00610?

The combination of genetics and ancestry to feed into health sounds like a good way to help develop new treatments.  23andMe has more than 13 million genotyped customers, 80 percent of whom have consented to participate in research. Scientists are able to study the aggregate, de-identified genetics of these millions of participants. Pairing this data alongside more than 4 billion self-reported health data points, their scientists use sophisticated analyses to identify potential drug targets.  In the case of 23ME-00610 above, they are targeting a receptor called CD200R1 expressed on T-cells and myeloid cells and may restore those cells’ ability to kill cancer cells in patients.  According to 23andMe, “Our hypothesis, backed by published research, is that drug targets based on human genetics are at least twice as likely to become successful medicines than those with no underlying human genetic evidence,” said Dr. Jennifer Low, Head of Therapeutics Development at 23andMe. “We hope that 23ME-00610 will ultimately show clinical benefit to patients with a number of types of cancer.”

Trial Summary

This is a Phase 1/2a Study of 23ME-00610 in Patients with Advanced Solid Malignancies.  The trial is due to end in June 2024 and the clinical trials document indicates up to 140 participants spread across the conditions listed:  Solid Tumor, Clear Cell Renal Cell Carcinoma, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Neuroendocrine Tumors, MSI-H Cancer, Cancer with a High Tumor Mutational Burden (TMB), Extensive-stage Small-cell Lung Cancer (SCLC).  There will be 15 slots for NETs and 15 for SCLC (technically a Neuroendocrine Carcinoma). 

This study includes a dose-escalation phase in Part A to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) followed by 6 monotherapy expansion arms in Part B to further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of 23ME-00610 in patients with solid malignancies.  Presumably Part A is Phase 1 and Part B is Phase 2A.  Phase 1 is complete and Phase 2A is underway. 

Cohort 3B will enroll up to 15 evaluable patients with locally advanced (unresectable) or metastatic neuroendocrine cancers (6b for SCLC). (See inclusion criteria below)

Contacts – (650) 963-8997,


Stanford Cancer Institute Palo Alto

Karmanos Cancer Institute Detroit

Oregon Health & Science University, Portland

MD Anderson Cancer Center Houston

START Center for Cancer Care San Antonio

Virginia Cancer Specialists Fairfax

Ottawa Hospital Cancer Centre

The Hospital for Sick Children, Toronto

Trial Eligibility Criteria

Key Inclusion Criteria:

  1. Part A: Adults ≥ 18 years of age; Part B: ≥ 12 to years of age, weighing at least 40 kg (total body weight)
  2. Part A: Histologically-diagnosed locally advanced (unresectable), or metastatic solid cancer that has progressed after all available standard therapy for the specific tumor type, or for which all available standard therapy has proven to be ineffective or if no further standard therapy exists.

    Part B:

    1. Cohort 1B: Histologically-diagnosed locally advanced (unresectable) or metastatic ccRCC that has progressed following all available standard therapy (e.g., anti-PD(L)-1, anti-vascular endothelial growth factor [VEGF] kinase inhibitors), or if no further standard therapy exists.
    2. Cohort 2B: Histologically-diagnosed locally advanced (unresectable) or metastatic, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma (i.e., disease recurrence within 6 months of completion of platinum-based therapy) that has progressed following all available standard therapy, or if no further standard therapy exists.
    3. Cohort 3B: The following histologically-diagnosed locally advanced (unresectable) or metastatic neuroendocrine cancers that have progressed following all available standard therapy, or if no further standard therapy exists:

      • Merkel cell carcinoma
      • Well-differentiated Grade 3 neuroendocrine cancers with unfavorable biology (as per National Comprehensive Cancer Network [NCCN] guidelines) from any site
      • Poorly differentiated neuroendocrine carcinoma (or extrapulmonary large and small cell carcinoma)
      • Patients with other cancers that show evidence of focal neuroendocrine differentiation may be included with approval from the medical monitor at 23andMe.
    4. Cohort 4B: Histologically-diagnosed locally advanced (unresectable) or metastatic solid cancer that has progressed following all available standard therapy, or if no further standard therapy exists and meets the following criteria:

      TMB-H solid cancer that has been confirmed by the FoundationOne CDx assay or other industry/institutional equivalent platform form TMB assessment using a cutoff of greater than or equal to 10 mutations/megabase and/or MSI-H solid cancer that has been confirmed by immunohistochemistry for MMR proteins or polymerase chain reaction (PCR) of microsatellites or MMR gene mutation by a next-generation sequencing (NGS) panel.

    5. Cohort 5B: In jurisdictions where local regulations and IRB/EC allows, adolescents with histologically-diagnosed locally advanced (unresectable), or metastatic solid cancer that has progressed after all available standard therapies for the specific tumor type, or if no further standard therapy exists.
    6. Cohort 6B: Histologically-diagnosed locally advanced (unresectable) or metastatic ES-SCLC that has progressed following all available standard therapy, or if no further standard therapy exists.
  3. Part A: Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Part B: Adolescents ≥ 12 to < 16 years of age: Lansky Play Scale ≥ 50; Adolescents ≥ 16 years of age: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  4. Life expectancy ≥ 12 weeks
  5. Part A: Patients without RECIST measurable disease (e.g., evaluable disease only) will be eligible for enrollment in Part A, regardless of tumor type; Part B: Patients enrolled in Part B must have measurable disease by per RECIST 1.1 and have ≥ 1 site of measurable disease that has not been previously irradiated.

Key Exclusion Criteria:

  1. Females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding.
  2. Immune Related Medical History:

    1. Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
    2. Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration
    3. History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis
    4. History of Grade ≥ 3 immune-mediated toxicity
  3. Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant.
  4. History of a positive test for:

    1. Hepatitis C virus (HCV) infection, except for those who have completed curative therapy for HCV and have undetectable HCV RNA
    2. Hepatitis B virus (HBV) infection, except for those who are receiving treatment with HBV-active nucleos(t)ide antiviral therapy at the time of study entry and have undetectable HBV DNA
    3. Human Immunodeficiency Virus (HIV) infection, except those who meet the following criteria: CD4+ T cells ≥ 350 cells/μL, no history of Acquired Immunodeficiency Syndrome (AIDS)-defining opportunistic infections, HIV RNA < 50 copies/mL, and on a stable antiretroviral regimen for at least 3 months.
  5. Prior radiation therapy with an inadequate washout between the last dose and the start of study drug, defined as follows: 1) at least 2 weeks for palliative radiation to the extremities for osseous bone metastases is required; 2) at least 4 weeks for radiation to the chest, brain, or visceral organs is required; and 3) at least 6 weeks for large-field radiation is required.
  6. Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter)
  7. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free.
  8. Recent history of cardiovascular disease
  9. Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis

Why is this trial important? 

Neuroendocrine Neoplasms have been called an “immunological desert” by one NET specialist.  But anything which looks like it may help to progress immunology further within Neuroendocrine Neoplasms is welcome.  Particularly if Grades 1 and 2 can be included at some point.

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 



I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me. 

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.   

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.


Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document  Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

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2 thoughts on “Clinical Trial: Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies (incl Neuroendocrine Neoplasms)

  • Catherine Arnott Smith

    I have been teaching a digital health class which includes a week on personal genetic testing services, including 23andme, for some years now and have a good deal of respect for the company, for what it’s worth.

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