Metastatic or Locally Advanced Unresectable Solid TumorsPhase 1NCT05198349
First in Human Study of M1069 in Advanced Solid Tumors
A Phase 1 study testing M1069 in people with Metastatic or Locally Advanced Unresectable Solid Tumors, run by EMD Serono Research & Development Institute, Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic or Locally Advanced Unresectable Solid Tumors
- What is being tested?
- M1069
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Mar 2022to 10 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)
Nashville, Tennessee, 37203
About this study
Official title: 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
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.
- Being tested
- M1069
- Keywords
- Adenosine antagonist, Adenosine receptor A2A/A2B antagonist, M1069
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M1069Drug
Participants received escalated oral dose of M1069, twice daily (BID) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
| Study group | Role | What they receive |
|---|---|---|
| M1069 | Experimental | Not described Receives: Drug: M1069 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (<) 7 days without signs. Other DLTs were Hy's Law hepatotoxicity without clear cause, vision changes (≥5-line Best Corrected Visual Acuity (BCVA) loss, BCVA <20/160, MD >9 decibel (dB), macular thickness >25 percentage (%)), severe eye disorders limiting self-care, ≥5-day drug interruption to prevent DLT.
Measured: Cycle 1 (first 21 days after first study drug administration)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs
An AE can be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. For surgical or diagnostic procedures, the condition/illness leading to such a procedure is considered as the AE rather than the procedure itself. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both serious TEAEs and non-serious TEAEs. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization, results in persistent disability. Treatment Related TEAEs are also reported.
Measured: Up to 16 months
Secondary outcomes (9)
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of M1069
The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
Measured: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Area Under Plasma Concentration Time Curve From Time Zero to 24, Divided by Dose (AUC [0-24]/D) of M1069
AUC [0-24]/D is the Area under plasma concentration time curve from time zero to 24 divided by dose (AUC [0-24]/D) of M1069. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
Measured: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Maximum Observed Plasma Concentration (Cmax) of M1069
Cmax is the maximum observed plasma concentration and was obtained directly from the concentration versus time curve.
Measured: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Maximum Observed Plasma (Peak) Drug Concentration, by Dose (Cmax/D)
Cmax/D is the maximum observed plasma concentration by dose. Cmax was obtained directly from the concentration versus time curve, divided by Dose of M1069.
Measured: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Measured: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
OR is defined as a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all target lesions. Number of participants with BOR of CR or PR was reported.
Measured: Time from first observation of response (CR or PR) up to planned assessment at 17.3 months
Duration of Response (DoR)
DoR is the time from when the complete response (CR) or partial response (PR) (whichever is first) criteria are first met until disease progression (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Measured: Time from first observation of response (CR or PR) up to planned assessment at 17.3 months
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
PFS is defined as the time (in months) from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was to be estimated using Kaplan-Meier (KM) plots.
Measured: Time from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within, whichever occurs first, assessed up to maximum of 17.3 months
Change From Baseline in Corrected QT (QTc) Interval
A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 10 minutes using an ECG machine. Change from baseline in QTc interval was reported. In the Timeframe the "C" refers to Cycle, "D" refers to Day and "h" refers to the hours.
Measured: Cycle (C)1Day (D)1: 1h, 2h, 4h, 6h, 8h post-dose; C1D8: 15min predose, 1h, 2h, 4h, 6h, 8h post-dose; C1D15: predose; C2D1: predose, 2h post-dose; C4D1, C6D1, C10D1, C12D1, C14D1, C18D1(each cycle is of 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start2 Mar 2022
- Primary completion9 May 2023
- Study completion10 Aug 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic or Locally Advanced Unresectable Solid TumorsStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Research & Development Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198349
- Sponsor's protocol ID
- MS201929_0032
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2022
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://bit.ly/IPD21
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05198349
- Acronym / sponsor ID
- MS201929_0032
- Keywords
- Adenosine antagonist, Adenosine receptor A2A/A2B antagonist, M1069
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M1069 | Experimental | Drug: M1069 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M1069Participants received escalated oral dose of M1069, twice daily (BID) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention. | Drug | M1069 |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (first 21 days after first study drug administration)
A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (<) 7 days without signs. Other DLTs were Hy's Law hepatotoxicity without clear cause, vision changes (≥5-line Best Corrected Visual Acuity (BCVA) loss, BCVA <20/160, MD >9 decibel (dB), macular thickness >25 percentage (%)), severe eye disorders limiting self-care, ≥5-day drug interruption to prevent DLT.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs
Time frame: Up to 16 months
An AE can be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. For surgical or diagnostic procedures, the condition/illness leading to such a procedure is considered as the AE rather than the procedure itself. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both serious TEAEs and non-serious TEAEs. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization, results in persistent disability. Treatment Related TEAEs are also reported.
9 secondary outcomes
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of M1069
Time frame: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Area Under Plasma Concentration Time Curve From Time Zero to 24, Divided by Dose (AUC [0-24]/D) of M1069
Time frame: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Maximum Observed Plasma Concentration (Cmax) of M1069
Time frame: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Maximum Observed Plasma (Peak) Drug Concentration, by Dose (Cmax/D)
Time frame: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Time frame: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
Time frame: Time from first observation of response (CR or PR) up to planned assessment at 17.3 months
Duration of Response (DoR)
Time frame: Time from first observation of response (CR or PR) up to planned assessment at 17.3 months
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
Time frame: Time from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within, whichever occurs first, assessed up to maximum of 17.3 months
Change From Baseline in Corrected QT (QTc) Interval
Time frame: Cycle (C)1Day (D)1: 1h, 2h, 4h, 6h, 8h post-dose; C1D8: 15min predose, 1h, 2h, 4h, 6h, 8h post-dose; C1D15: predose; C2D1: predose, 2h post-dose; C4D1, C6D1, C10D1, C12D1, C14D1, C18D1(each cycle is of 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://bit.ly/IPD21
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono Research & Development Institute, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M1069 in people with Metastatic or Locally Advanced Unresectable Solid Tumors, run by EMD Serono Research & Development Institute, Inc. at 3 sites in 2 countries.
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 8 inclusion and 9 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 22 Apr 2026. 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, Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (first 21 days after first study drug administration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.