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Monoclonal Antibodies

Phase 1 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by 23andMe, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until disease progression (up to 5 years)

Awards & highlights

Study Summary

This trial is testing a new drug called 23ME-01473 in patients with advanced solid cancers who have not responded well to standard treatments. The study aims to assess the safety, how well the

Who is the study for?

This trial is for adults over 18 with advanced solid cancers that have worsened after standard treatments. They should be relatively active (good performance status) and expected to live at least 12 more weeks. It's open to various cancer types as long as the disease can be evaluated.Check my eligibility

What is being tested?

The study is testing a new drug, 23ME-01473, given through an IV. It aims to see how safe it is, how the body handles it, and if it works against different advanced solid tumors in patients who've run out of treatment options.See study design

What are the potential side effects?

Since this is a first-in-human study for the drug 23ME-01473, specific side effects are not yet known but may include typical reactions related to IV infusions such as pain or swelling at the injection site, fever, chills or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until disease progression (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until disease progression (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until disease progression (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ORR based on investigator assessment against RECIST 1.1 criteria

Phase 1 Incidence and severity of serious adverse events (SAEs)

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

+1 more

Secondary outcome measures

Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473

Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473

Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1Experimental Treatment1 Intervention

Participants will receive escalating doses of 23ME-01473

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

23andMe, Inc.Lead Sponsor

9 Previous Clinical Trials

83,849 Total Patients Enrolled

Jennifer Low, M.D,Ph.DStudy Director23andMe, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this clinical research study?

"To be eligible for this study, individuals must have solid neoplasms and fall within the age range of 18 to 110 years. The trial aims to recruit approximately 82 participants."

Answered by AI

What is the collective count of participants who are joining this medical research study?

"Affirmative. Information on clinicaltrials.gov reveals that this trial is currently seeking volunteers. The study was first listed on March 7th, 2024, and most recently revised on March 21st, 2024. Researchers aim to recruit 82 participants from a single site."

Answered by AI

Are there ongoing efforts to actively enroll participants for this clinical trial?

"As per clinicaltrials.gov, this research endeavor is actively in search of eligible candidates. The study's initial posting was on March 7th, 2024, and the most recent revision took place on March 21st of the same year."

Answered by AI

Does this research include individuals aged 40 and above?

"Participants must be aged between 18 to 110 years old to meet the eligibility criteria for this research study. It is noteworthy that there are a total of 342 trials catering specifically to individuals under 18 and another set of 2576 aimed at those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study of 23ME-01473 in Patients With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06290388.

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