protocolSection identificationModule nctId: NCT06380816, orgStudyIdInfo id: CRUKD/24/001, secondaryIdInfos id: ISRCTN26628699, type: REGISTRY, domain: ISRCTN, briefTitle: A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cancer Research UK, class: OTHER, collaborators name: UCB Biopharma SRL, descriptionModule briefSummary: This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.The four main aims of the clinical trial are to find out:1. The best dose of UCB4594 that can be given safely to participants in the trial.2. What the side effects of UCB4594 are and how they can be managed.3. What happens to UCB4594 inside the body and how it affects cancer cells.4. Whether UCB4594 can cause cancer to shrink., conditionsModule conditions: Advanced Solid Tumours, conditions: Squamous Cell Carcinoma of Head and Neck, conditions: Carcinoma, Non-Small-Cell Lung, conditions: Colorectal Neoplasms, conditions: Triple Negative Breast Neoplasms, conditions: Carcinoma, Renal Cell (Clear Cell Only), conditions: Esophageal Neoplasms, conditions: Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors), conditions: Uterine Cervical Neoplasms, conditions: Ovarian Neoplasms, conditions: Pancreatic Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 167, type: ESTIMATED, armsInterventionsModule interventions name: UCB4594, outcomesModule primaryOutcomes measure: Recommended Phase 2 dose (RP2D) of UCB4594, primaryOutcomes measure: Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles)., secondaryOutcomes measure: Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules)., secondaryOutcomes measure: Maximum concentration of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Minimum concentration of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Area under the curve of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Clearance of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Christie NHS Foundation Trust, city: Manchester, country: United Kingdom, contacts name: Fiona Thistlethwaite, Prof, role: CONTACT, phone: +44 (0)161 9187672, email: fiona.thistlethwaite@nhs.net, geoPoint lat: 53.48095, lon: -2.23743, locations facility: University Hospital Southampton NHS Foundation Trust, city: Southampton, country: United Kingdom, contacts name: Ioannis Karydis, Prof, role: CONTACT, email: I.Karydis@soton.ac.uk, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False