Clinical trial • Phase I/II • Oncology
PUMITAMIG for Hepatocellular carcinoma (advanced or unresectable)
Phase I/II trial of PUMITAMIG for Hepatocellular carcinoma (advanced or unresectable).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hepatocellular carcinoma (advanced or unresectable)
- Trial Stage
- Phase I/II
- Drug Modality
- Peptide/protein/enzyme|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 12-12-2025
- First CTIS Authorization Date
- 22-04-2026
Trial design
Randomised, open-label, atezolizumab with bevacizumab (comparator arm; doses and schedule not specified in available documents).-controlled, adaptive Phase I/II trial in Spain, Poland, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Atezolizumab with Bevacizumab (comparator arm; doses and schedule not specified in available documents).
- Adaptive
- True, Phase 1 includes dose-finding to determine the optimal dose (dose-escalation/dose-finding); specific interim analysis schedules or stopping rules not specified in provided data.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 82
Eligibility
Recruits 82 isVulnerablePopulationSelected: false; participants must be ≥ 18 years or legal adult according to local regulation (consent by legal adult participant)..
- Vulnerable Population
- isVulnerablePopulationSelected: false; participants must be ≥ 18 years or legal adult according to local regulation (consent by legal adult participant).
Inclusion criteria
- {"criterion_text":"- Age of Participant must be ≥ 18 years of age, or legal adult age according to the local regulation inclusive, at the time of signing the ICF."}
- {"criterion_text":"- People with a certain kind of advanced liver cancer (HCC) that can't be removed by surgery."}
- {"criterion_text":"- People who can still do most everyday things on their own."}
- {"criterion_text":"- People whose liver is working well."}
- {"criterion_text":"- People who haven't had certain treatments for their liver cancer before."}
- {"criterion_text":"- People who have at least one tumor that shows up on a scan."}
Exclusion criteria
- {"criterion_text":"- People with rare types of liver cancer."}
- {"criterion_text":"- People who have serious bleeding problems or are likely to bleed easily."}
- {"criterion_text":"- People who have had an organ transplant or have immune system diseases."}
- {"criterion_text":"- People with high blood pressure that can’t be controlled, even with medicine."}
- {"criterion_text":"- People whose urine has too much protein (sign of kidney problems)."}
- {"criterion_text":"- People taking strong blood-thinning medicines."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The main goal of phase 1 will check and count for how many people have problems or serious problems from the medicine, if anyone must stop taking it because of these problems, and if any problems cause death.","definition_or_measurement_approach":"Count of participants experiencing adverse events or serious adverse events, treatment discontinuations due to toxicity, and deaths related to study treatment (safety/tolerability assessment)."}
- {"endpoint_text":"- The main goal of phase 2 will be to check and count how many people's liver cancer gets much smaller or completely goes away with the treatment (OR (Objective Response) confirmed CR (complete response) or PR (partial response)).","definition_or_measurement_approach":"Objective Response Rate (ORR): confirmed complete response (CR) or partial response (PR) assessed per objective response criteria (confirmed CR or PR)."}
Secondary endpoints
- {"endpoint_text":"- To check how many people’s liver cancer gets much smaller or goes away (cancer shrinkage).","definition_or_measurement_approach":"Assessment of tumor response (shrinkage) measured as objective response (CR/PR)."}
- {"endpoint_text":"- To count how many people have problems or serious problems from the medicines, including those who stop treatment or die because of them (safety)","definition_or_measurement_approach":"Counts of adverse events, serious adverse events, treatment discontinuations, and deaths related to study drugs."}
- {"endpoint_text":"- To measure how much pumitamig is in the blood after treatment and before the next dose (pumitamig levels).","definition_or_measurement_approach":"Pharmacokinetic measurement of pumitamig plasma concentrations post-dose and pre-next dose."}
- {"endpoint_text":"- To measure how much ipilimumab is in the blood before the next dose (ipilimumab levels).","definition_or_measurement_approach":"Pharmacokinetic measurement of ipilimumab trough concentrations prior to next dosing."}
- {"endpoint_text":"- To see if people’s bodies make fighters against the medicines (anti-drug antibodies).","definition_or_measurement_approach":"Assessment of anti-drug antibodies (immunogenicity) to study drugs."}
- {"endpoint_text":"- To see how long people live without the cancer getting worse, and how long the cancer stays smaller or goes away (progression delay (PFS, Progression-Free Survival and duration (DOR, Duration of Response).","definition_or_measurement_approach":"Time-to-event endpoints: Progression-Free Survival (PFS) and Duration of Response (DOR) measured from baseline to progression or death and from response to progression, respectively."}
Recruitment
- Planned Sample Size
- 82
- Recruitment Window Months
- 66
- Consent Approach
- Written informed consent is required from each participant (legal adults, ≥18 years). Subject information and informed consent form (ICF) documents are available in country-specific versions (examples in the document list: Spanish, Polish, French, German, Italian). No assent process (minors) is indicated.
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 47
Spain
- Earliest CTIS Part Ii Submission Date
- 09-04-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 15
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Liver Unit
- Principal Investigator Name
- Bruno Sangro
- Principal Investigator Email
- bsangro@unav.es
- Contact Person Name
- Bruno Sangro
- Contact Person Email
- bsangro@unav.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Gastroenterology
- Principal Investigator Name
- Ana María Matilla Peña
- Principal Investigator Email
- XXXXXXXXX@XXXXXXXX
- Contact Person Name
- Ana María Matilla Peña
- Contact Person Email
- XXXXXXXXX@XXXXXXXX
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Liver Unit
- Principal Investigator Name
- Bruno Sangro
- Principal Investigator Email
- bsangro@unav.es
- Contact Person Name
- Bruno Sangro
- Contact Person Email
- bsangro@unav.es
Poland
- Earliest CTIS Part Ii Submission Date
- 09-04-2026
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Mtz Clinical Research Powered By Pratia
- Principal Investigator Name
- Krzysztof Wozniak
- Principal Investigator Email
- badacz@pratia.com
- Contact Person Name
- Krzysztof Wozniak
- Contact Person Email
- badacz@pratia.com
- Site Name
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Osrodek Badan Klinicznych Wczesnych Faz
- Principal Investigator Name
- Bozena Cybulska-Stopa
- Principal Investigator Email
- obkwf@dcopih.pl
- Contact Person Name
- Bozena Cybulska-Stopa
- Contact Person Email
- obkwf@dcopih.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badan Klinicznych Osrodek Badan Klinicznych Wczesnych Faz
- Principal Investigator Name
- Piotr Wysocki
- Principal Investigator Email
- nszmukala@uck.gda.pl
- Contact Person Name
- Piotr Wysocki
- Contact Person Email
- nszmukala@uck.gda.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 83
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Medical Clinic 1
- Principal Investigator Name
- Jens Marquardt
- Principal Investigator Email
- jens.marquardt@uksh.de
- Contact Person Name
- Jens Marquardt
- Contact Person Email
- jens.marquardt@uksh.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Department of Gastroenterology and Hepatology
- Principal Investigator Name
- Dirk Waldschmidt
- Principal Investigator Email
- dirk-thomas.waldschmidt@uk-koeln.de
- Contact Person Name
- Dirk Waldschmidt
- Contact Person Email
- dirk-thomas.waldschmidt@uk-koeln.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Department of Internal Medicine 1
- Principal Investigator Name
- Jörg Trojan
- Principal Investigator Email
- trojan@em.uni-frankfurt.de
- Contact Person Name
- Jörg Trojan
- Contact Person Email
- trojan@em.uni-frankfurt.de
France
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 84
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Service d'Hépato-Gastroentérologie et d'Oncologie Digestive
- Principal Investigator Name
- Jean-Marc Phelip
- Principal Investigator Email
- j.marc.phelip@chu-st-etienne.fr
- Contact Person Name
- Jean-Marc Phelip
- Contact Person Email
- j.marc.phelip@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Digestive Oncology
- Principal Investigator Name
- Jean-Frédéric Blanc
- Principal Investigator Email
- jean-frederic.blanc@chu-bordeaux.fr
- Contact Person Name
- Jean-Frédéric Blanc
- Contact Person Email
- jean-frederic.blanc@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- HepartoGastroentérologie
- Principal Investigator Name
- Thomas Decaens
- Principal Investigator Email
- TDecaens@chu-grenoble.fr
- Contact Person Name
- Thomas Decaens
- Contact Person Email
- TDecaens@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hépatology
- Principal Investigator Name
- Pierre Nahon
- Principal Investigator Email
- Pierre.nahon@aphp.fr
- Contact Person Name
- Pierre Nahon
- Contact Person Email
- Pierre.nahon@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 20
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Ilario Giovanni Rapposelli
- Principal Investigator Email
- ilario.rapposelli@irst.emr.it
- Contact Person Name
- Ilario Giovanni Rapposelli
- Contact Person Email
- ilario.rapposelli@irst.emr.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Operative unit of Oncology and Hematology
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@cancercenter.humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. Oncologia Medica 2
- Principal Investigator Name
- Caterina Vivaldi
- Principal Investigator Email
- caterina.vivaldi@gmail.com
- Contact Person Name
- Caterina Vivaldi
- Contact Person Email
- caterina.vivaldi@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Mural Health Technologies Inc.
- Responsibilities
- Clinical Trial Payment - Subject Reimbursement and Financial Services
- Name
- Medidata Solutions Inc.
- Responsibilities
- Data Management Platform
- Name
- Iqvia Inc.
- Responsibilities
- Site Payments
- Name
- Accenture Solutions Private Limited
- Responsibilities
- Pharmacovigilance duties: Medical review and Cases Data Entry; Embarc operations
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab
Third parties
- {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Clinical Trial Payment - Subject Reimbursement and Financial Services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry; Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BNT327 50 mg ml
- Active Substance
- PUMITAMIG
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- BNT327 20 mg ml
- Active Substance
- PUMITAMIG
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- IPILIMUMAB
- Active Substance
- IPILIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- ATEZOLIZUMAB
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- ATEZOLIZUMAB
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- BEVACIZUMAB
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Ipilimumab
- Active Substance
- IPILIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 1
- Combination Treatment
- Yes
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