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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290388
• Other study ID #: 23ME-01473-CLIN-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 7, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: 23andMe, Inc.
• Contact: Study Inquiry
• Phone: 650-963-8997
• Email: studyinquiry[@]23andme.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• 23ME-01473
23Me-01473 given by intravenous infusion

Locations

Country	Name	City	State
United States	START Midwest	Grand Rapids	Michigan
United States	Oregon Health & Science University	Portland	Oregon
United States	START Center for Cancer Care	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
23andMe, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1:Incidence and severity of dose-limiting toxicities (DLTs)		First dose through 21 days post dose
Primary	Phase 1: Incidence and severity of adverse events (AEs)		From Screening through 90 days post treatment
Primary	Phase 1 Incidence and severity of serious adverse events (SAEs)		From Screening through 90 days post treatment
Primary	ORR based on investigator assessment against RECIST 1.1 criteria		From baseline until disease progression (up to 5 years)
Secondary	Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473		From first dose up to 5 days post treatment discontinuation
Secondary	Phase 1: Objective response rate (ORR)	ORR based on investigator assessment against RECIST 1.1 criteria	From baseline until disease progression (up to 5 years)
Secondary	Duration of response (DoR)	Duration of response based on investigator assessment against RECIST 1.1 criteria	From baseline until disease progression (up to 5 years)
Secondary	Disease Control Rate (DCR)	Disease control rate based on investigator assessment against RECIST 1.1 criteria	From baseline until disease progression (up to 5 years)
Secondary	Progression free survival (PFS)	Progression free survival based on investigator assessment against RECIST 1.1 criteria	From baseline until disease progression (up to 5 years)
Secondary	Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473		[Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]
Secondary	Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473		[Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]
Secondary	Last measurable serum concentration (Clast) following a single dose of 23ME-01473		[Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]
Secondary	Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473		[Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]
Secondary	Terminal half-life (T1/2) following a single dose of 23ME-01473		[Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose]
Secondary	Maximum serum concentration (Cmax) following multiple doses of 23ME-01473		[Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]
Secondary	Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473		[Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]
Secondary	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: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]
Secondary	Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473		[Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]
Secondary	Terminal half-life (T1/2) following multiple doses of 23ME-01473		[Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]