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A Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

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

NCT05199272•23andMe, Inc.

View on ClinicalTrials.gov

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

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).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

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
+6 more criteria

Locations (13)

Stanford Cancer Institute

Palo Alto, California, United States

Emory University

Atlanta, Georgia, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

R.J.Zuckerberg Cancer Center

Lake Success, New York, United States

Cohen Children's Medical Center

New Hyde Park, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

START Center for Cancer Care

San Antonio, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Key Dates

Start Date

December 29, 2021

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

November 15, 2024

Enrollment

141

ESTIMATED participants

Conditions

Solid TumorClear Cell Renal Cell CarcinomaEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaNeuroendocrine TumorsMSI-H CancerCancer With A High Tumor Mutational BurdenExtensive-stage Small-cell Lung Cancer

Interventions

23ME-00610

DRUG

A Study of PYX-201 in Advanced Solid Tumors

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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