First in Human Study of M1069 in Advanced Solid Tumors (NCT05198349) | Clinical Trial Compass
TerminatedPhase 1
First in Human Study of M1069 in Advanced Solid Tumors
Stopped: Overarching portfolio-level review of the company's oncology pipeline resulted in early termination of the study. The study was not terminated due to safety.
United States, Canada15 participantsStarted 2022-03-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* Other protocol defined inclusion criteria could apply
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 cri…
What they're measuring
1
Number of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: Cycle 1 (first 21 days after first study drug administration)
2
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs
Timeframe: Up to 16 months
Trial details
NCT IDNCT05198349
SponsorEMD Serono Research & Development Institute, Inc.