A Phase 1/2a, Multicenter, Open-label, Dose Escalation and Expansion Study of Intravenously Administered 23ME-01473 in Participants With Advanced Solid Malignancies

23andMe, Inc.3 sites in 1 country5 target enrollmentMarch 7, 2024

ConditionsSolid Tumor

Interventions23ME-01473

Drugs23ME-01473

Overview

Phase: Phase 1
Intervention: 23ME-01473
Conditions: Solid Tumor
Sponsor: 23andMe, Inc.
Enrollment: 5
Locations: 3
Primary Endpoint: Phase 1: Incidence and severity of adverse events (AEs)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 7, 2024

End Date

November 10, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

23andMe, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Arms & Interventions

Phase 1

Participants will receive escalating doses of 23ME-01473

Intervention: 23ME-01473

Outcomes

Primary Outcomes

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

Time Frame: From Screening through 90 days post treatment

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 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)

Secondary Outcomes

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)
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)])
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)])
Progression free survival (PFS)(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))
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))
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])