Crescendo Biologics Ltd.
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
Advanced and/or Metastatic Solid Tumours
CB307
PHASE1
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 70 participants |
| Masking : | NONE |
| Masking Description : | Open Label multi center non randomised study. |
| Primary Purpose : | TREATMENT |
| Official Title : | A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients With PSMA+ Advanced and/or Metastatic Solid Tumours |
| Actual Study Start Date : | 2021-06-08 |
| Estimated Primary Completion Date : | 2024-07-25 |
| Estimated Study Completion Date : | 2024-09-25 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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University of Washington
Seattle, Washington, United States, 98109-5311
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Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066 CX
WITHDRAWN
Byc research.v
Amsterdam, North Holland, Netherlands, 1081 HV
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University Medical Center Groningen,
Groningen, Netherlands, P.O. Box 30 001
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Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands,
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UMC Utrecht Cancer Center
Utrecht, Netherlands, 3584 CX
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Clinic University of Navarra
Pamplona, Navarra, Spain, 31008
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Clinic Hospital in Barcelona
Barcelona, Spain, 08036
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Hospital of the Holy Cross and Sant Pau
Barcelona, Spain, 08041
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Clinic University of Navarra
Madrid, Spain, 28027
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Hu Fundacion Jimenez Diaz
Madrid, Spain, 28040
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October 12 University Hospital
Madrid, Spain, 28041
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HM Sanchinarro University Hospital
Madrid, Spain, 28050
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NEXT Oncology Hospital Quironsalud Madrid
Madrid, Spain, 28050
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Hu Virgen de la Arrixaca
Murcia, Spain, 30120
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Hu Virgen del Rocio - PPDS
Sevilla, Spain, 41013
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The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
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Royal Marsden Hospital
London, Surrey, United Kingdom, SM2 5pt
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University College London Hospitals NHS Foundation Trust
London, United Kingdom, Nw1 2bu
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Sarah Cannon Research Institute, UK
London, United Kingdom, W1G 6AD