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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 2B: Histologically-diagnosed locally advanced (unresectable) or metastatic, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma (i.e., disease recurrence within 6 months of completion of platinum-based therapy) that has progressed following all available standard therapy, or if no further standard therapy exists
Part B: Adolescents ≥ 12 to < 16 years of age: Lansky Play Scale ≥ 50; Adolescents ≥ 16 years of age: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Must not have
Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis
Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug for safety and how well it works in patients with cancer who have already tried other treatments.
Who is the study for?
This trial is for adults and adolescents with various advanced solid cancers that have worsened despite all standard treatments. Specific conditions include certain neuroendocrine, ovarian, renal cell, and small cell lung cancers. Participants must be in relatively good physical condition with a life expectancy of at least 12 weeks.
What is being tested?
The study tests the safety and effectiveness of a new drug called 23ME-00610 administered via IV to patients with advanced solid tumors who've exhausted standard therapies. It's an early-phase trial assessing how the body processes the drug and its preliminary effects on cancer.
What are the potential side effects?
As this is a first-in-human study, specific side effects are not yet known but may include typical reactions to cancer drugs such as fatigue, nausea, inflammation at infusion sites, allergic reactions or changes in blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian, fallopian tube, or peritoneal cancer is advanced, cannot be surgically removed, and has not responded to platinum-based treatment.
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I am a teenager with good physical function.
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I am 12 years or older and weigh at least 40 kg.
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My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.
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I am an adult with a good level of physical activity.
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My kidney cancer has worsened after all standard treatments.
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My small cell lung cancer is advanced, cannot be surgically removed, and has not responded to all standard treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled brain metastases or meningitis from cancer.
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I have had a bone marrow or solid organ transplant.
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I am not pregnant or breastfeeding.
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I have had a severe reaction to immune therapy.
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I have a history of certain lung conditions not caused by infections.
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I have had heart problems recently.
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I haven't had cancer treatment in the last 4 weeks or within 5 half-lives of the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part B: Objective response rate (ORR)
Secondary study objectives
Disease Control Rate (DCR)
Duration of response (DoR)
Part A: Objective response rate (ORR)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 Intervention
Patients will receive the recommended dose(s) of 23ME-00610
Group II: Part AExperimental Treatment1 Intervention
Patients will receive escalating doses of 23ME-00610
Find a Location
Who is running the clinical trial?
23andMe, Inc.Lead Sponsor
9 Previous Clinical Trials
83,790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one tumor that can be measured and hasn't been treated with radiation.My ovarian, fallopian tube, or peritoneal cancer is advanced, cannot be surgically removed, and has not responded to platinum-based treatment.You have advanced kidney or ovarian cancer that has not responded to standard treatments, or there are no more standard treatment options available for you.I am a teenager with good physical function.I have had hepatitis C or B, or HIV, but it's either treated or undetectable.I am a teenager with advanced cancer that has not responded to all standard treatments.I am 12 years or older and weigh at least 40 kg.I have an autoimmune disease treated with strong medication in the last 2 years.In some places, teenagers with certain types of advanced or spreading solid cancer that hasn't responded to standard treatments may be included. For adults, they must have a good performance status and a life expectancy of at least 12 weeks. For Part B, patients must have specific types of measurable disease.I have advanced neuroendocrine cancer that has worsened after all standard treatments.I have advanced neuroendocrine cancer that has not responded to standard treatments.My cancer can't be measured using standard scans but I can join Part A of the study.My cancer is advanced, has not responded to standard treatments, and is either TMB-H or MSI-H.I do not have uncontrolled brain metastases or meningitis from cancer.I have had a bone marrow or solid organ transplant.I am not pregnant or breastfeeding.I had cancer before, but it was cured with surgery alone over 2 years ago.You are expected to live for at least 12 weeks.I haven't taken any immune-weakening drugs in the last 4 weeks.I recently had radiation therapy without enough time before starting the study drug.I have had a severe reaction to immune therapy.I have a history of certain lung conditions not caused by infections.My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.I have had heart problems recently.I am 18 years old or older.I am an adult with a good level of physical activity.My kidney cancer has worsened after all standard treatments.I haven't had cancer treatment in the last 4 weeks or within 5 half-lives of the drug.My small cell lung cancer is advanced, cannot be surgically removed, and has not responded to all standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part A
- Group 2: Part B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Solid Tumors Patient Testimony for trial: Trial Name: NCT05199272 — Phase 1 & 2
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