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

NCT06290388 | Terminated Phase 1 FDA Drug

• 1 other identifier: 23ME-01473-CLIN-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Solid Tumor

Keywords

Cancer; Phase 1; Solid Tumor; Oncology; NK; ULBP6; Immunotherapy

Outcome Measures

Primary Outcomes (4)

• Phase 1:Incidence and severity of dose-limiting toxicities (DLTs)

  First dose through 21 days post dose

• Phase 1: Incidence and severity of adverse events (AEs)

  From Screening through 90 days post treatment

• Phase 1 Incidence and severity of serious adverse events (SAEs)

  From Screening through 90 days post treatment

• ORR based on investigator assessment against RECIST 1.1 criteria

  From baseline until disease progression (up to 5 years)

Secondary Outcomes (15)

• Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473

  From first dose up to 5 days post treatment discontinuation

• Phase 1: Objective response rate (ORR)

  From baseline until disease progression (up to 5 years)

• Duration of response (DoR)

  From baseline until disease progression (up to 5 years)

• Disease Control Rate (DCR)

  From baseline until disease progression (up to 5 years)

• Progression free survival (PFS)

  From baseline until disease progression (up to 5 years)

Study Arms (1)

Phase 1

EXPERIMENTAL

Participants will receive escalating doses of 23ME-01473

Drug: 23ME-01473

Interventions

23ME-01473 DRUG

23Me-01473 given by intravenous infusion

Phase 1

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1: Adults ≥ 18 years of age
• Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type.
• Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy ≥ 12 weeks
• Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression.

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 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.
• Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis
• Recent history (within 6 months) of serious cardiovascular disease

Sponsors & Collaborators

• 23andMe, Inc.: lead

Study Sites (3)

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jennifer Low, M.D,Ph.D

  23andMe, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 4, 2024
• Study Start: March 7, 2024
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-06

Locations

US (3)