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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516615-25-00 | Registry Identifier | CTIS (EU) |
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In this study, researchers want to learn about the safety of a new drug, BAY 3547926, and how well the drug works in people with a type of liver cancer called advanced hepatocellular carcinoma (HCC), which has a special protein called Glypican 3 (GPC3). Researchers want to find the best dose of BAY 3547926 for people with advanced HCC and look at the way the body absorbs and distributes the drug.
The study drug, BAY 3547926, delivers a radioactive agent to cancer cells. The radioactive agent emits radiations which can damage the cancer cells and cause them to die. These radiations travel a small distance, so are expected to cause little damage to surrounding healthy tissues. This is the first study of BAY 3547926 in humans.
Participants will take part in one of the 4 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3547926 alone in Part 2 or with other treatments in Parts 3 and 4 of the study.
During the study, the doctors and their study team will do health check-ups, take pictures (scans) of the body, collect blood and urine samples, and ask participants questions about how they are feeling and what health problems they are having.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY 3547926 | Experimental | actinium-225 labeled antibody conjugate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 3547926 | Drug | antibody conjugate with actinium-225 label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (dose escalation): Occurrence and severity of TEAEs | TEAE=Treatment emergent adverse event | up to 60 months after first administration |
| Part 1 (dose escalation): Recommended safe and active dose (RSAD) | The RSAD is based on incidence of DLT and preliminary anti-tumor activity (ORR using RECIST 1.1 by Investigator assessment) informed by TITE-CRM. RSAD=Recommended safe and active dose DLT=Dose limiting toxicity ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors TITE-CRM =Time-to-event continual reassessment method | up to 60 months after first administration |
| Part 2 (dose expansion): Occurrence and severity of TEAEs | TEAE=Treatment emergent adverse event | up to 60 months after first administration |
| Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment | ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment | DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment | DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (dose escalation): Recommended dose level(s) based on occurrence and severity of TEAEs and DLTs, PK, immunogenicity, and preliminary anit-tumor activity (ORR using RECIST 1.1 by Investigator assessment) | TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dothan | Recruiting | Dothan | Alabama | 36303 | United States |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| BAY 3547922 |
| Drug |
antibody conjugate without actinium-225 label as preinjection |
|
| additional intervention | Drug | optional additional intervention |
|
| Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment |
PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors |
| up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs | TEAE=Treatment emergent adverse event | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment | ORR= Objective response rate | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment | DCR=Disease control rate | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment | DoR=Duration of response | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment | PFS=Progression free survivial | up to 60 months after first administration |
| Part 1 (dose escalation): Recommended dosing regimen based on occurrence and severity of TEAEs and DLTs, PK, immunogenicity, and preliminary anti-tumor activity (ORR using RECIST 1.1 by Investigator assessment) | TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Part 1 (dose escalation): ORR using RECIST 1.1 by investigator assessment | ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Part 1 (dose escalation): DCR using RECIST 1.1 by investigator assessment | DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Part 1 (dose escalation): DoR using RECIST 1.1 by investigator assessment | DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors | Up to 60 months after first administration |
| Part 1 (dose escalation): PFS using RECIST 1.1 by investigator assessment | PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors | up to 60 months after first administration |
| Part 1 (dose escalation): Cmax of BAY 3547926 after a single dose and after multiple doses | Cmax=Maximal blood concentration | up to 36 weeks after first administration |
| Part 1 (dose escalation): AUC of BAY 3547926 after a single dose and after multiple doses | AUC=Area under the blood concentration versus time curve | up to 36 weeks after first administration |
| Part 1 (dose escalation): Clearance of BAY 3547926 after a single dose and after multiple doses if data allow | PK=Pharmacokinetic | up to 36 weeks after first administration |
| Part 2 (dose expansion): Recommended dose based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments | PK=Pharmacokinetic IG=Immunogenicity | up to 36 months after first administration |
| Part 2 (dose expansion): Recommended schedule based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments | PK=Pharmacokinetic IG=Immunogenicity | up to 36 months after first administration |
| Part 2 (dose expansion): Cmax of BAY 3547926 after a single dose and after multiple doses | Cmax=maximal blood concentration | up to 36 weeks after first administration |
| Part 2 (dose expansion): AUC of BAY 3547926 after a single dose and after multiple doses | AUC=Area under curve of blood concentration versus time curve | up to 36 weeks after first administration |
| Part 2 (dose expansion): Clearance of BAY 3547926 after single dose and after multiple doses, where applicable and if data allow | PK=Pharmacokinetic | up to 36 weeks after first administration |
| Parts 3 and 4 (dose expansion in combination): Recommended dose level(s) of BAY 3547926 based on clinical data including, but not limited to, occurrence and severity of TEAEs and DLTs, PK and IG | TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): Recommended dosing regimen of BAY 3547926 based on clinical data including, but not limited to, occurrence and severity of TEAEs and DLTs, PK and IG | TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): Recommended schedule of BAY 3547926 based on severity of TEAEs, PK, IG | TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): Cmax of BAY 3547926 after a single dose and after multiple doses of BAY 3547926 in combination | Cmax=maximal blood concentration | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): AUC of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination | AUC=Area under curve of blood concentration versus time curve | up to 60 months after first administration |
| Parts 3 and 4 (dose expansion in combination): Clearance of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination, where applicable and if data allow | PK=Pharmacokinetic | up to 60 months after first administration |
| Duarte | Recruiting | Duarte | California | 91010 | United States |
| Edegem | Recruiting | Edegem | Antwerp | 2650 | Belgium |
| Leuven | Recruiting | Leuven | Flemish Brabant | 3000 | Belgium |
| Kortrijk | Recruiting | Kortrijk | West Flanders | 8500 | Belgium |
| Toronto | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
| Montreal | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Sherbrooke | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Xuhui District | Recruiting | Xuhui | Shanghai Municipality | 200032 | China |
| Tampere | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
| Turku | Recruiting | Turku | Southwest Finland | 20540 | Finland |
| Montpellier | Recruiting | Montpellier | Occitanie | 34298 | France |
| L'Hospitalet de Llobregat | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Madrid | Recruiting | Madrid | Madrid | 28050 | Spain |
| Pamplona | Recruiting | Pamplona | Spain |
| London | Recruiting | London | Greater London | NW3 2QG | United Kingdom |
| London | Recruiting | London | Greater London | W12 0HS | United Kingdom |
| Glasgow | Recruiting | Glasgow | Scotland | G12 0YN | United Kingdom |
| Sutton | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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