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

NCT05199272 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 23ME-00610-CLIN-001
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 13

Brief 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

Conditions

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; Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

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

  21 days

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

  21 days

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

  Up to 90 days post treatment

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

  Up to 90 days post treatment

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

  Up to 90 days post treatment

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

  Up to 90 days post treatment

Secondary Outcomes (2)

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

  Up to 5 days post treatment discontinuation

• Overall survival (OS)

  Up to 5 years

Study Arms (2)

Part A

EXPERIMENTAL

Patients will receive escalating doses of 23ME-00610

Drug: 23ME-00610

Part B

EXPERIMENTAL

Patients will receive the recommended dose(s) of 23ME-00610

Drug: 23ME-00610

Interventions

23ME-00610 DRUG

23ME-00610 given by IV infusion

Part A; Part B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• 23andMe, Inc.: lead

Study Sites (13)

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

R.J.Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

Location

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Neuroendocrine Tumors; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: December 29, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); CA (3)