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An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1179470 (Dose escalation) | Experimental | BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. |
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| BAY1179470 (additional) | Experimental | Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. |
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| BAY1179470 (expansion) | Experimental | Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1179470 | Drug | BAY1179470 will be administered as a 1-hour intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events as a Measure of Safety and Tolerability | Up to 2 years | |
| Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470 | Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days | |
| Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration | Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. | Every 42 days |
| Biomarker (plasma) | Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days |
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Inclusion Criteria:
For subjects in the additional cohort:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kashiwa | Chiba | 277-8577 | Japan | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Biomarker (biopsy) | Additional cohort only | Cycle 1: pre-dose and Day 8; cycle 1 is 21 days |
| Immunogenicity | Analyzed for anti-BAY 1179470 antibodies | Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days |
| Kita-Adachigun |
| Saitama |
| 362-0806 |
| Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Koto-ku | Tokyo | 135-8550 | Japan |
| Fukuoka | 811-1395 | Japan |
| Singapore | 119074 | Singapore |
| Singapore | 169610 | Singapore |
| Seoul | 138-736 | South Korea |