A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

BAY 3547926: antibody conjugate with actinium-225 label

BAY 3547922: antibody conjugate without actinium-225 label as preinjection

BAY 3713391: Radioactive imaging agent - optional preinjection

BAY 3713389: optional preinjection

Study summary

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.

Eligibility

Primary outcome measure(s)

• Part 1 (dose escalation): Occurrence and severity of TEAEs — up to 60 months after first administration
  TEAE=Treatment emergent adverse event
• Part 1 (dose escalation): Recommended safe and active dose (RSAD) — up to 60 months after first administration
  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
• Part 2 (dose expansion): Occurrence and severity of TEAEs — up to 60 months after first administration
  TEAE=Treatment emergent adverse event
• Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors
• Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors
• Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors
• Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors
• Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs — up to 60 months after first administration
  TEAE=Treatment emergent adverse event
• Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  ORR= Objective response rate
• Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  DCR=Disease control rate
• Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  DoR=Duration of response
• Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment — up to 60 months after first administration
  PFS=Progression free survivial

Trial sites (24)

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