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Solid TumorPhase 1/2NCT06290388

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

A Phase 1/2 study testing 23ME-01473 in people with Solid Tumor, run by 23andMe, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Solid Tumor
What is being tested?
23ME-01473
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesUnited States
Study dates
7 Mar 2024to 10 Nov 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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
  • 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
  • Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter)
  • History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free.
  • Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis
  • Recent history (within 6 months) of serious cardiovascular disease

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • START Midwest

    Grand Rapids, Michigan, 49546

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • START Center for Cancer Care

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Solid Tumor
Being tested
23ME-01473
Keywords
Cancer, Phase 1, Solid Tumor, Oncology, NK, ULBP6, Immunotherapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 23ME-01473Drug

    23Me-01473 given by intravenous infusion

Study groups in NCT06290388
Study groupRoleWhat they receive
Phase 1ExperimentalParticipants will receive escalating doses of 23ME-01473
Receives: Drug: 23ME-01473

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1:Incidence and severity of dose-limiting toxicities (DLTs)

    Measured: First dose through 21 days post dose

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

    Measured: From Screening through 90 days post treatment

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

    Measured: From Screening through 90 days post treatment

  4. ORR based on investigator assessment against RECIST 1.1 criteria

    Measured: From baseline until disease progression (up to 5 years)

Secondary outcomes (15)

  1. Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473

    Measured: From first dose up to 5 days post treatment discontinuation

  2. Phase 1: Objective response rate (ORR)

    ORR based on investigator assessment against RECIST 1.1 criteria

    Measured: From baseline until disease progression (up to 5 years)

  3. Duration of response (DoR)

    Duration of response based on investigator assessment against RECIST 1.1 criteria

    Measured: From baseline until disease progression (up to 5 years)

  4. Disease Control Rate (DCR)

    Disease control rate based on investigator assessment against RECIST 1.1 criteria

    Measured: From baseline until disease progression (up to 5 years)

  5. Progression free survival (PFS)

    Progression free survival based on investigator assessment against RECIST 1.1 criteria

    Measured: From baseline until disease progression (up to 5 years)

  6. Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473

    Measured: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]

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

    Measured: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]

  8. Last measurable serum concentration (Clast) following a single dose of 23ME-01473

    Measured: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]

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

    Measured: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose)]

  10. Terminal half-life (T1/2) following a single dose of 23ME-01473

    Measured: [Time Frame: Cycle 1 (21 days, from Cycle 1 Day 1 predose to Cycle 2 Day 1 predose]

  11. Maximum serum concentration (Cmax) following multiple doses of 23ME-01473

    Measured: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]

  12. Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473

    Measured: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]

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

    Measured: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]

  14. Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473

    Measured: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]

  15. Terminal half-life (T1/2) following multiple doses of 23ME-01473

    Measured: [Time Frame: Cycle 4 (21 days, from Cycle 4 Day 1 predose to Cycle 5 Day 1 predose)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start7 Mar 2024
  3. Primary completion10 Nov 2024
  4. Study completion10 Nov 2024

Why it stopped: Sponsor cancelled study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290388
Sponsor's protocol ID
23ME-01473-CLIN-001
Status last verified
Jun 2024
First submitted
8 Feb 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 23ME-01473 in people with Solid Tumor, run by 23andMe, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor cancelled study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1:Incidence and severity of dose-limiting toxicities (DLTs) (time frame: First dose through 21 days post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06290388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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