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First in Human Study of M1069 in Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

First in Human Study of M1069 in Advanced Solid Tumors

First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M1069 in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors

NCT05198349•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants who had histologically or cytologically proven locally advanced or metastatic solid malignancies and who are refractory to or have progressed under standard treatment or for whom standard treatment is not expected to deliver clinical benefit
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening
•Adequate hematological function, hepatic function and renal function
•Ability to swallow oral dose forms (for example \[e.g.\] capsules)
•Fresh tumor biopsies mandatory for participants at Dose level 2 (DL2) and 6 participants upon potential determination of Recommended Dose for Expansion (RDE). Providing consent to fresh tumor biopsies taken during the Screening period and an on-treatment biopsy is mandatory
•Life expectancy of at least 12 weeks according to Investigator judgement
•Measurable disease according to The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Exclusion Criteria

•Persisting toxicity related to prior therapy Grade greater than (\>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, however, alopecia, sensory neuropathy hypothyroidism and diabetes mellitus Grade less than or equal to (\<=) 2, despite treatment, are allowed
•Prior organ transplantation including allogeneic stem cell transplantation
•Participants with known brain metastases, except those meeting the following criteria: a) Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; b) No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
•Participants must be either off steroids or on a stable or decreasing dose of \< 10 milligrams (mg) daily prednisone (or equivalent)
•Current significant cardiac conduction abnormalities, including corrected QT interval (QTcF, corrected with Fridericia formula) prolongation of \> 470 milliseconds (ms) or impaired cardiovascular function, ventricular tachycardia (including Torsades de Pointes), or a history of paroxysmal atrial fibrillation, serious cardiac arrhythmia and family history of sudden death or long QT syndrome
•Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent including but not limited to inflammatory bowel diseases, autoimmune hepatitis, interstitial lung disease of immunologic origin, systemic lupus erythematosus, et cetera (etc.), with the following exceptions: a) Participants with diabetes type I, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
•Significant acute or chronic fungal, bacterial and/or viral infections requiring systemic therapy including coronavirus disease of 2019 (COVID-19)
•Known hypersensitivity to the trial treatment or to one or more of the excipients

Locations (3)

Hackensack University Medical Center

Hackensack, New Jersey, United States

Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

Nashville, Tennessee, United States

Princess Margaret Cancer Centre

Toronto, Canada

Key Dates

Start Date

March 2, 2022

Primary Completion Date

May 9, 2023

Completion Date

August 10, 2023

Last Updated

November 25, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions

M1069

DRUG

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)

NCT04170153

Metastatic or Locally Advanced Unresectable Solid Tumors

View study

TERMINATEDPHASE1

First-in-Human Study of MS201408-0005A as Single Agent and in Combinations

NCT03306420

Metastatic or Locally Advanced Unresectable Solid Tumors

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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