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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004584-46 | EudraCT Number |
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FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and tolerability to determine MTD and preliminary RP2D.In addition this study will assess the safety and efficacy of CB307 when given in combination with pembrolizumab (KEYTRUDA®) in patients with metastatic PSMA+ castration-resistant cancer
FIH, Phase 1, open-label, multi centre, non randomised study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours (Part 1 & 2A) and patients with metastatic PSMA+ castration-resistant cancer (Part 2B) . The study will consist of a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) which will consist of 2 arms . Part 2 will evaluate safety and preliminary efficacy of CB307 (both as monotherapy and in combination with pembrolizumab) at the MTD or preliminary RP2D as determined in Part 1. Approximately 70 patients will participate in total. Patients will receive either CB307 alone or CB307 with pembrolizumab IV (Part 2B), until loss of clinical benefit, unacceptable toxicity, withdrawal of consent or end of study. The dose escalation may be adapted by the SRC based on clinical experience and safety review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A | Experimental | Patients will receive CB307 IV infused every 7 days. Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2A arm will enrol patients with PSMA+ solid tumours. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months. |
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| Multi center open label Dose Escalation followed by Combination Cohort Expansion : Part 2B | Experimental | Patients will receive CB307 IV infused every 7 days in combination with KEYTRUDA® (pembrolizumab) IV infused every 21 days . Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2B arm will enrol patients with PSMA+ metastatic castration-resistant prostate cancer. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CB307 | Drug | Tri-specific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | The objective of the study is to assess the safety and tolerability of the study drug CB307 and to determine the MTD (maximum tolerated dose) | The nature and frequency of any DLTs during the DLT-monitoring period assessed based on NCI CTCAE v5.0. up to 20 months duration. |
| Number of participants with treatment-related adverse events with CB307 in combination with pembrolizumab as assessed by CTCAE v5.0 | The objective of the study is to assess the safety and tolerability of the study drug CB307 in combination with pembrolizumab to assess safety and tolerability of the combined treatment regimen | The nature and frequency of any DLTs during the DLT-monitoring period for participants with combination therapy, assessed based on NCI CTCAE v5.0. up to 20 months duration. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate clinical efficacy measured as progression-free survival according to RECIST v.1.1 or PCWG3 | To measure how well the treatment succeeds in producing the desired effect. | Progression-free survival according to RECIST v1.1 or PCWG3 up to 20 months duration; and change from baseline in anti-drug (CB307) antibodies (ADA up to 20 months duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MD | Contact | 01223497140 | Clinicaltrials@crescendobiologics.com | |
| MD | Contact | 012234947140 | info@crescendobiologics.com |
| Name | Affiliation | Role |
|---|---|---|
| K Hashimoto | Crescendo Biologics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98109-5311 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38957926 | Derived | Wilford T, Bartlett PD, Schlag A, Jasaitis L, Pandha H, Pierce AJ, Hughes R. Solving selectivity issues in LBAs: case study using Gyrolab to quantify CB307, a bispecific Humabody in human serum. Bioanalysis. 2024;16(14):757-769. doi: 10.1080/17576180.2024.2365545. Epub 2024 Jul 3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 13, 2024 | |
| Reset | Jan 28, 2025 |
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Initial dose escalation cohorts followed by dose expansion cohorts consisting of 2 arms, monotherapy and combination therapy cohorts .
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Open Label multi center non randomised study.
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| To evaluate clinical efficacy and duration of response by radiographic progression free survival (rPFS) | To measure how well the treatment succeeds in producing the desired effect. | radiographic progression free survival up to 20 months duration; |
| To evaluate anti-tumor response according to RECIST v.1.1 or PCWG3 | To measure how well the treatment succeeds in producing the desired effect. | anti-tumor response according to RECIST v1.1 or PCWG3 up to 20 months duration; |
| To measure how the body processes CB307 in the body over time | To evaluate the pharmacokinetic trough levels before administration of CB307 | PK parameters of CB307: data collected at time point 0 at each dosing period up to 20 months duration. |
| Pharmacokinetic of CB307 T1/2 | To evaluate the pharmacokinetic T1/2 after 3rd dose via IV for multiple dose levels of CB307 | Data collected up to 20 months duration. |
| Pharmacokinetic of CB307 Tmax | To evaluate the pharmacokinetic Tmax after 3rd dose via IV for multiple dose levels of CB307 | Data collected up to 20 months duration. |
| To measure Tumour Immune response | To determine the potential of CB307 to produce an immune response and assess the relationship with other outcome measures | Tumor response per RECIST ver 1.1 up to 20 months duration |
| Relationship of CB307 to anti tumour response | To evaluate the preliminary CB307 dose in relationship to activity of changes in tumour | PSA response defined as a >50% decrease in PSA up to 20 months duration |
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
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| VUMC Research B.V | Withdrawn | Amsterdam | North Holland | 1081 HV | Netherlands |
| University Medical Center Groningen, | Recruiting | Groningen | P.O. Box 30 001 | Netherlands |
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| Erasmus University Medical Center Rotterdam | Recruiting | Rotterdam | Netherlands |
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| UMC Utrecht Cancer Center | Recruiting | Utrecht | 3584 CX | Netherlands |
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| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| hospital clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| hospital de la Sanat Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
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| Clinica Universidad de Navarra | Recruiting | Madrid | 28027 | Spain |
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| HU Fundacion Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
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| NEXT Oncology Hospital Quironsalud Madrid | Recruiting | Madrid | 28050 | Spain |
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| HU Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
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| HU Virgen del Rocio - PPDS | Recruiting | Seville | 41013 | Spain |
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| The Christie NHS Foundation Trust | Recruiting | Manchester | Greater Manchester | M20 4BX | United Kingdom |
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| Royal Marsden Hospital | Recruiting | London | Surrey | SM2 5PT | United Kingdom |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | NW1 2BU | United Kingdom |
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| Sarah Cannon Research Institute, UK | Recruiting | London | W1G 6AD | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 13, 2024 | Jan 28, 2025 |