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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514921-45-00 | Other Identifier | EU CTR |
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Study was terminated due to decision made not to proceed with the clinical trial DDRiver 521, that has not yet commenced enrolment, for strategic reasons.
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1 (Dose Finding): M9466 + Carboplatin | Experimental |
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| Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab | Experimental |
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| Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M9466 | Drug | Participants will receive an escalating doses of M9466 orally in 21-day cycles until disease progression, intolerable toxicity, death, withdrawal of study or study consent, lost to follow-up, or end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Module 1 and Module 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs | Time from signing Informed Consent Form (ICF) up to 30 days after end of study intervention (approximately assessed up to 24 months) | |
| Module 1 and Module 2: Number of Participants with Dose-limiting Toxicity (DLT) | Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Module 1 and Module 2: Pharmacokinetic (PK) Plasma Concentration of M9466 | Pre-dose up to 6 hours post-dose on Cycle 1 Day 1; Pre-dose on Cycle 1 Day 4 and Cycle 1 Day 8 (each cycle is of 21 days) | |
| Module 1 and Module 2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Assessed by Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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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 bit.ly/IPD21
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| Carboplatin | Drug | Carboplatin will be administered intravenously on Day 1 of each 21-day cycle. |
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| Etoposide | Drug | Etoposide will be administered intravenously as per standard of care. |
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| Atezolizumab | Drug | Atezolizumab will be administered intravenously as per standard of care. |
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| M9446 | Drug | M9446 dose will be further investigated in Module 2 Part A of the study. |
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| M9446 | Drug | M9446 recommended Dose for Expansion (RDE) will be further investigated in Module 2 Part B of the study. |
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| Carboplatin | Drug | Carboplatin will be administered intravenously as per standard of care. |
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| Time from first treatment of study intervention up to planned assessment at 24 months |
| Module 1 and Module 2: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by the Investigator | Time from first treatment of study intervention up to planned assessment at 24 months |
| Module 1 and Module 2: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator | Time from first treatment of study intervention up to planned assessment at 24 months |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |