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Solid TumorPhase 1/2NCT05199272

A Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies

A Phase 1/2 study testing 23ME-00610 in people with Solid Tumor and Clear Cell Renal Cell Carcinoma, run by 23andMe, Inc. at 13 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
23ME-00610
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
13 sitesin 2 countries
Study dates
29 Dec 2021to Mar 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Part A: Adults ≥ 18 years of age; Part B: ≥ 12 to years of age, weighing at least 40 kg (total body weight)
  • 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:
  • 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.
  • 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.
  • 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:
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  • 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.
  • 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 forTMB 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.
  • 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.
  • 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.
  • 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;
  • Life expectancy ≥ 12 weeks
  • 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.

Who cannot join

  • Females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding.
  • Immune Related Medical History:
  • Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
  • Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration
  • History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis
  • History of Grade ≥ 3 immune-mediated toxicity
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  • Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant.
  • History of a positive test for:
  • Hepatitis C virus (HCV) infection, except for those who have completed curative therapy for HCV and have undetectable HCV RNA
  • 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
  • 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.
  • 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.
  • Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter)
  • History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free.
  • Recent history of cardiovascular disease
  • Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States10 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • R.J.Zuckerberg Cancer Center

    Lake Success, New York, 11042

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • START Center for Cancer Care

    San Antonio, Texas, 78229

Other trials in United States

Canada3 sites

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

Official title: A Phase 1/2a, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered 23ME-00610 in Patients With Advanced Solid Malignancies

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

Read the detailed description

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.

5 tumor- specific monotherapy expansion cohort will enroll up to 15 patients/cohort with the following locally advanced (unresectable) or metastatic solid malignancies:

  1. Clear cell renal cell carcinoma (ccRCC)
  2. Epithelial ovarian, fallopian tube or primary peritoneal carcinoma
  3. Neuroendocrine cancers
  4. Microsatellite instability-high (MSI-H) and/or tumor mutational burden-high (TMB-H) solid cancers and
  5. Extensive stage Small cell lung cancer (ES-SCLC)

A cohort of up to 8 evaluable adolescent patients with locally advanced (unresectable), or metastatic solid cancers will also be enrolled.

Approximately 15 additional evaluable patients will be added to the cohorts with Epithelial ovarian, fallopian tube or primary peritoneal carcinoma and Neuroendocrine cancers in Part B to evaluate another dose level with pharmacologic or PD evidence of therapeutic effect below the MTD/RP2D identified in Part A (for a maximum of 30 patients in total at the alternate dose).

Being tested
23ME-00610
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Neuroendocrine Tumors, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 23ME-00610Drug

    23ME-00610 given by IV infusion

Study groups in NCT05199272
Study groupRoleWhat they receive
Part AExperimentalPatients will receive escalating doses of 23ME-00610
Receives: Drug: 23ME-00610
Part BExperimentalPatients will receive the recommended dose(s) of 23ME-00610
Receives: Drug: 23ME-00610

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence and severity of dose-limiting toxicities (DLTs)

    Measured: 21 days

  2. Part B adolescents: Incidence and severity of dose-limiting toxicities (DLTs)

    Measured: 21 days

  3. Part A: Incidence and severity of adverse events (AEs)

    Measured: Up to 90 days post treatment

  4. Part B adolescents: Incidence and severity of adverse events (AEs)

    Measured: Up to 90 days post treatment

  5. Part A: Incidence and severity of serious adverse events (SAEs)

    Measured: Up to 90 days post treatment

  6. Part B adolescents: Incidence and severity of serious adverse events (SAEs)

    Measured: Up to 90 days post treatment

Secondary outcomes (2)

  1. Part A: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-00610

    Measured: Up to 5 days post treatment discontinuation

  2. Overall survival (OS)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start29 Dec 2021
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
141 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05199272
Sponsor's protocol ID
23ME-00610-CLIN-001
Status last verified
May 2024
First submitted
6 Jan 2022
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kummar S, Razak AA, Laurie S, Glatt DM, Kell S, Diep AN, Schmidt M, Hom C, German C, Shringarpure SS, Majeed SR, Rasco D. First-in-Human Study of 23ME-00610, an Antagonistic Antibody for Genetically Validated CD200R1 Immune Checkpoint, in Participants with Advanced Solid Malignancies. Cancer Res Commun. 2025 Jan 1;5(1):94-105. doi: 10.1158/2767-9764.CRC-24-0568.

    PubMed 39651931

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 23ME-00610 in people with Solid Tumor and Clear Cell Renal Cell Carcinoma, run by 23andMe, Inc. at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence and severity of dose-limiting toxicities (DLTs) (time frame: 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05199272, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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