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

• ClinicalTrials.gov Identifier: NCT06290388
• Recruitment Status: Recruiting
• First Posted: March 4, 2024
• Last Update Posted: March 22, 2024
• Sponsor: 23andMe, Inc.
• Information provided by (Responsible Party): 23andMe, Inc.

Tracking Information

• First Submitted Date: February 8, 2024
• First Posted Date: March 4, 2024
• Last Update Posted Date: March 22, 2024
• Actual Study Start Date: March 7, 2024
• Estimated Primary Completion Date: June 30, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2024)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2024)

• Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473 [ Time Frame: From first dose up to 5 days post treatment discontinuation ]
• 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
• 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
• 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
• 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
• 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)] ]
• 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)] ]
• 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)] ]
• 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)] ]
• 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] ]
• 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)] ]
• 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)] ]
• 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)] ]
• 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)] ]
• 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)] ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of 23ME-01473 in Patients With Advanced Solid Malignancies
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor

Intervention

Drug: 23ME-01473

23Me-01473 given by intravenous infusion

Study Arms

Experimental: Phase 1

Participants will receive escalating doses of 23ME-01473

Intervention: Drug: 23ME-01473

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 26, 2024): 82
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2026
• Estimated Primary Completion Date: June 30, 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 110 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06290388
• Other Study ID Numbers: 23ME-01473-CLIN-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: 23andMe, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: 23andMe, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jennifer Low, M.D,Ph.D; 23andMe, Inc.

• PRS Account: 23andMe, Inc.
• Verification Date: March 2024