account_circleRecruiting
hepatocellular carcinoma
Bayer Identifier:
22262
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2024-516615-25-00
A first-in-human study to learn about the safety of BAY 3547926 and how well it works in participants with advanced liver cancer
Trial purpose
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). 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 3 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 Part 3 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.
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 3 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 Part 3 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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
148Trial Dates
February 2025 - December 2033Phase
Phase 1Could I Receive a placebo
NoProducts
BAY3547926Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Princess Margaret Cancer Centre – University Health Network - Department of Medical Oncology and Hematology | Toronto, M5G 2C4, Canada |
Recruiting | Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopi | Montreal, H2X 0A9, Canada |
Not yet recruiting | Royal Marsden NHS Foundation Trust | Sutton - Gastrointestinal Unit | Sutton, SM2 5PT, United Kingdom |
Not yet recruiting | Imperial College London | London, W12 0HS, United Kingdom |
Not yet recruiting | McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM) | Montreal, H4A 3J1, Canada |
Not yet recruiting | CIUSSS de l'Estrie-CHUS | Sherbrooke, J1H 5N4, Canada |
Primary Outcome
- Part 1 (dose escalation): Occurrence and severity of TEAEsTEAE=Treatment emergent adverse eventdate_rangeTime Frame: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 methoddate_rangeTime Frame:up to 60 months after first administration
- Part 2 (dose expansion): Occurrence and severity of TEAEsTEAE=Treatment emergent adverse eventdate_rangeTime Frame:up to 60 months after first administration
- Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessmentORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessmentDCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessmentDoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessmentPFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): Occurrence and severity of TEAEsTEAE=Treatment emergent adverse eventdate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessmentORR= Objective response ratedate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessmentDCR=Disease control ratedate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessmentDoR=Duration of responsedate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessmentPFS=Progression free survivialdate_rangeTime Frame:up to 60 months after first administration
Secondary Outcome
- 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 Tumorsdate_rangeTime Frame: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 Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 1 (dose escalation): ORR using RECIST 1.1 by investigator assessmentORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 1 (dose escalation): DCR using RECIST 1.1 by investigator assessmentDCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 1 (dose escalation): DoR using RECIST 1.1 by investigator assessmentDoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:Up to 60 months after first administration
- Part 1 (dose escalation): PFS using RECIST 1.1 by investigator assessmentPFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumorsdate_rangeTime Frame:up to 60 months after first administration
- Part 1 (dose escalation): Cmax of BAY 3547926 after a single dose and after multiple dosesCmax=Maximal blood concentrationdate_rangeTime Frame:up to 36 weeks after first administration
- Part 1 (dose escalation): AUC of BAY 3547926 after a single dose and after multiple dosesAUC=Area under the blood concentration versus time curvedate_rangeTime Frame: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 allowPK=Pharmacokineticdate_rangeTime Frame: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 assessmentsPK=Pharmacokinetic IG=Immunogenicitydate_rangeTime Frame: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 assessmentsPK=Pharmacokinetic IG=Immunogenicitydate_rangeTime Frame:up to 36 months after first administration
- Part 2 (dose expansion): Cmax of BAY 3547926 after a single dose and after multiple dosesCmax=maximal blood concentrationdate_rangeTime Frame:up to 36 weeks after first administration
- Part 2 (dose expansion): AUC of BAY 3547926 after a single dose and after multiple dosesAUC=Area under curve of blood concentration versus time curvedate_rangeTime Frame: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 allowPK=Pharmacokineticdate_rangeTime Frame:up to 36 weeks after first administration
- Part 3 (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 IGTEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicitydate_rangeTime Frame:up to 60 months after first administration
- Part 3 (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 IGTEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicitydate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): Recommended schedule of BAY 3547926 based on severity of TEAEs, PK, IGTEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicitydate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): Cmax of BAY 3547926 after a single dose and after multiple doses of BAY 3547926 in combinationCmax=maximal blood concentrationdate_rangeTime Frame:up to 60 months after first administration
- Part 3 (dose expansion in combination): AUC of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combinationAUC=Area under curve of blood concentration versus time curvedate_rangeTime Frame:up to 60 months after first administration
- Part 3 (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 allowPK=Pharmacokineticdate_rangeTime Frame:up to 60 months after first administration
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1