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

Phase 1

Terminated

• Conditions: Solid Tumor
• Interventions: Drug: 23ME-01473

• Registration Number: NCT06290388
• Lead Sponsor: 23andMe, Inc.

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 Timeline

• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Study Start: 2024-03-07
• Status Verified: 2024-06
• Primary Completion: 2024-11-10
• Study Completion: 2024-11-10
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1	23ME-01473	Participants will receive escalating doses of 23ME-01473

Primary Outcome Measures

Name	Time	Method
Phase 1: Incidence and severity of adverse events (AEs)	From Screening through 90 days post treatment
Phase 1:Incidence and severity of dose-limiting toxicities (DLTs)	First dose through 21 days post dose
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 Outcome Measures

Name	Time	Method
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)]
Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473	From first dose up to 5 days post treatment discontinuation
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)]
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)]
Duration of response (DoR)	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)	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)	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: 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: 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: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 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: 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: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]
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)]
Phase 1: Objective response rate (ORR)	From baseline until disease progression (up to 5 years)	ORR based on investigator assessment against RECIST 1.1 criteria
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]

Trial Locations

Locations (3)

START Midwest; 🇺🇸 Grand Rapids, Michigan, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

START Center for Cancer Care; 🇺🇸 San Antonio, Texas, United States