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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06290388
Recruitment Status : Recruiting
First Posted : March 4, 2024
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
23andMe, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: 23ME-01473 Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Multicenter, Open-label, Dose Escalation and Expansion Study of Intravenously Administered 23ME-01473 in Participants With Advanced Solid Malignancies
Actual Study Start Date : March 7, 2024
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1
Participants will receive escalating doses of 23ME-01473
 Drug: 23ME-01473
23Me-01473 given by intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1:Incidence and severity of dose-limiting toxicities (DLTs) [ Time Frame: First dose through 21 days post dose ]
  2. Phase 1: Incidence and severity of adverse events (AEs) [ Time Frame: From Screening through 90 days post treatment ]
  3. Phase 1 Incidence and severity of serious adverse events (SAEs) [ Time Frame: From Screening through 90 days post treatment ]
  4. ORR based on investigator assessment against RECIST 1.1 criteria [ Time Frame: From baseline until disease progression (up to 5 years) ]

Secondary Outcome Measures :
  1. Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473 [ Time Frame: From first dose up to 5 days post treatment discontinuation ]
  2. Phase 1: Objective response rate (ORR) [ Time Frame: From baseline until disease progression (up to 5 years) ]
    ORR based on investigator assessment against RECIST 1.1 criteria

  3. Duration of response (DoR) [ Time Frame: From baseline until disease progression (up to 5 years) ]
    Duration of response based on investigator assessment against RECIST 1.1 criteria

  4. Disease Control Rate (DCR) [ Time Frame: From baseline until disease progression (up to 5 years) ]
    Disease control rate based on investigator assessment against RECIST 1.1 criteria

  5. Progression free survival (PFS) [ Time Frame: From baseline until disease progression (up to 5 years) ]
    Progression free survival based on investigator assessment against RECIST 1.1 criteria

  6. Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473 [ Time Frame: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)] ]
  7. Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473 [ Time Frame: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)] ]
  8. Last measurable serum concentration (Clast) following a single dose of 23ME-01473 [ Time Frame: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)] ]
  9. Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473 [ Time Frame: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)] ]
  10. Terminal half-life (T1/2) following a single dose of 23ME-01473 [ Time Frame: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose] ]
  11. Maximum serum concentration (Cmax) following multiple doses of 23ME-01473 [ Time Frame: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)] ]
  12. Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473 [ Time Frame: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)] ]
  13. Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473 [ Time Frame: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)] ]
  14. Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473 [ Time Frame: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)] ]
  15. Terminal half-life (T1/2) following multiple doses of 23ME-01473 [ Time Frame: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)] ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06290388


Contacts
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Contact: Study Inquiry 650-963-8997 studyinquiry@23andme.com

Locations
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United States, Texas
START Center for Cancer Care Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
23andMe, Inc.
Investigators
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Study Director: Jennifer Low, M.D,Ph.D 23andMe, Inc.
More Information
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Responsible Party: 23andMe, Inc.
ClinicalTrials.gov Identifier: NCT06290388    
Other Study ID Numbers: 23ME-01473-CLIN-001
First Posted: March 4, 2024    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 23andMe, Inc.:
Cancer
Phase 1
Solid Tumor
Oncology
 NK
ULBP6
Immunotherapy
Additional relevant MeSH terms:
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Neoplasms