Study of 23ME-01473 in Patients With Advanced Solid Malignancies

Trial Title: Study of 23ME-01473 in Patients With Advanced Solid Malignancies

NCT ID: NCT06290388

Condition: Solid Tumor

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Cancer
Phase 1
Solid Tumor
Oncology
NK
ULBP6
Immunotherapy

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 23ME-01473
Description: 23Me-01473 given by intravenous infusion
Arm group label: Phase 1

Summary: This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.

Detailed description: This study includes a dose escalation portion to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) to evaluate the clinical activity of 23ME-01473 and further evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with solid malignancies.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Phase 1: Adults ≥ 18 years of age 2. Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type. 3. Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 4. Life expectancy ≥ 12 weeks 5. Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression. 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 3. 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 5. Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter) 6. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. 7. Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis 8. Recent history (within 6 months) of serious cardiovascular disease

Gender: All

Minimum age: 18 Years

Maximum age: 110 Years

Healthy volunteers: No

Locations:

Facility:
Name: START Midwest

Address:
City: Grand Rapids
Zip: 49546
Country: United States

Status: Recruiting

Facility:
Name: Oregon Health & Science University

Address:
City: Portland
Zip: 97239
Country: United States

Status: Recruiting

Facility:
Name: START Center for Cancer Care

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Start date: March 7, 2024

Completion date: June 30, 2026

Lead sponsor:
Agency: 23andMe, Inc.
Agency class: Industry

Source: 23andMe, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06290388