NCT05199272

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

Active, enrolled Phase 1/Phase 2 Last updated 13 November 2024

What this trial tests

Phase 1/Phase 2 trial testing 23ME-00610 in Solid Tumor in 141 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 December 2021

Primary endpoint
1 March 2025

1 March 2025

Quick facts

Lead sponsor	23andMe, Inc.
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	141
Start date	29 December 2021
Primary completion	1 March 2025
Estimated completion	1 March 2025
Sites	13 locations across United States, Canada

Drugs / interventions tested

• 23ME-00610 — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Clear Cell Renal Cell Carcinoma — all drugs for Clear Cell Renal Cell Carcinoma →
• Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →

Sponsor

23andMe, Inc. — full company profile →

Who can join

12 and older, any sex, with Solid Tumor or Clear Cell Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Part A: Incidence and severity of dose-limiting toxicities (DLTs)
  Time frame: 21 days
• Part B adolescents: Incidence and severity of dose-limiting toxicities (DLTs)
  Time frame: 21 days
• Part A: Incidence and severity of adverse events (AEs)
  Time frame: Up to 90 days post treatment
• Part B adolescents: Incidence and severity of adverse events (AEs)
  Time frame: Up to 90 days post treatment
• Part A: Incidence and severity of serious adverse events (SAEs)
  Time frame: Up to 90 days post treatment
• Part B adolescents: Incidence and severity of serious adverse events (SAEs)
  Time frame: Up to 90 days post treatment

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. 23ME-00610, a genetically informed, first-in-class antibody targeting CD200R1 to enhance antitumor T cell function.
   Fenaux J, Fang X, Huang YM, Melero C, et al · · 2023 · cited 14× · PMID 37288324 · DOI 10.1080/2162402x.2023.2217737
2. CD200R signaling contributes to unfavorable tumor microenvironment through regulating production of chemokines by tumor-associated myeloid cells.
   Lin CH, Talebian F, Li Y, Zhu J, et al · · 2023 · cited 7× · PMID 37275530 · DOI 10.1016/j.isci.2023.106904
3. First-in-Human Study of 23ME-00610, an Antagonistic Antibody for Genetically Validated CD200R1 Immune Checkpoint, in Participants with Advanced Solid Malignancies.
   Kummar S, Razak AA, Laurie S, Glatt DM, et al · · 2025 · cited 2× · PMID 39651931 · DOI 10.1158/2767-9764.crc-24-0568
4. CD200R1 immune checkpoint blockade by the first-in-human anti-CD200R1 antibody 23ME-00610: molecular mechanism and engineering of a surrogate antibody.
   Melero C, Budiardjo SJ, Daruwalla A, Larrabee L, et al · · 2024 · cited 2× · PMID 39402718 · DOI 10.1080/19420862.2024.2410316
5. Treatment approaches for non-metastatic small cell bladder cancer: a meta-analysis of reconstructed Kaplan-Meier curves.
   Mose L, Maitre P, Eberz P, Zilli T, et al · · 2025 · PMID 40895775 · DOI 10.1016/j.ctro.2025.101032