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

Active:	No
Cancer Type:	Gynecologic Cancers Lung Cancer Primary Peritoneal Cancer	NCT ID:	NCT05199272
Trial Phases:	Phase I Phase II	Protocol IDs:	23ME-00610-CLIN-001 (primary) NCI-2022-03572
Eligibility:	12 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	23andMe, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05199272

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

Objectives

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).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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