Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M4076 · 1 trial · 1 indication
A DLT was defined as the occurrence of any of following events that were judged by the study investigator, received at least 80% of the planned cumulative dose during the DLT period of each study intervention and completed the DLT period or additionally, participants who did not receive 80% of the planned total dose of study intervention, but at least 80% dosing of a different dose cohort and finished the DLT period are eligible for the DLT analysis set to be analyzed in the highest dose cohort for which they received 80% of dosing.
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs.
Vital sign assessments included assessments of heart rate, diastolic blood pressure, systolic blood pressure, weight, respiratory rate and temperature. Clinical significance was assessed by the investigator. Number of participants who with clinically significant changes from baseline in vital signs were reported.
The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with change from baseline to grade 3 or higher values for the hematology and biochemistry were reported.
ECG parameters included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, QT intervals, and corrected QT(QTc) intervals. Clinical significance was determined by the investigator. Number of participants with clinically significant change from baseline in 12-lead ECG were reported.
| Arm | Type | Description |
|---|---|---|
| Part 1A Dose Escalation: M4076 100 mg | EXPERIMENTAL | Participants received M4076 film coated tablets at a dose of 100 milligrams (mg), orally once daily in 21-day cycles, starting from Day 1 of each cycle disease progression, death, AE leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurred first, or End of Study |
| Part 1A Dose Escalation: M4076 200 mg | EXPERIMENTAL | Participants received M4076 film coated tablets at a dose of 200 mg, orally once daily in 21-day cycles, starting from Day 1 of each cycle disease progression, death, AE leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurred first, or End of Study. |
| Part 1A Dose Escalation: M4076 300 mg | EXPERIMENTAL | Participants received M4076 film coated tablets at a dose of 300 mg, orally once daily in 21-day cycles, starting from Day 1 of each cycle disease progression, death, AE leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurred first, or End of Study. |
| Part 1A Dose Escalation: M4076 400 mg | EXPERIMENTAL | Participants received M4076 film coated tablets at a dose of 400 mg, orally once daily in 21-day cycles, starting from Day 1 of each cycle disease progression, death, AE leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurred first, or End of Study. |
| Name | Type | Description |
|---|---|---|
| M4076 | DRUG | M4076 was administered orally. |
Inclusion Criteria: * Participants with advanced solid tumors, for whom no standard of care therapy exists or for whom is not considered sufficiently effective, or who cannot tolerate standard of care * Participants with Eastern Cooperative Oncology Group Performance status 0 or 1 * Adequate hemato...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
M4076 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, and a first-in-human study has been completed to evaluate its safety and efficacy in patients with advanced solid tumors.
The molecular target of M4076 has not been disclosed. It is a small molecule being studied in the context of biomarker-selected patients with advanced solid tumors, suggesting it may act on a specific molecular pathway relevant to tumor growth.
M4076 is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate the drug's potential in oncology.
M4076 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical evaluation.
M4076 has been studied in one clinical trial, identified as NCT04882917, titled 'First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)'. This Phase 1 study enrolled 22 participants and has been completed.
No alternative names for M4076 have been disclosed. It is identified solely by its code name M4076 in clinical trial registries and scientific literature.