Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.

Status unconfirmed · Phase 1

Conditions studied: Advanced and/or Metastatic Solid Tumours

In brief

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

Key facts

Study ID

NCT04839991

Run by

Crescendo Biologics Ltd.

People needed

70

Starts

2021-06-08

Expected to finish

2024-09-25

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of understanding the written informed consent
• Aged at least 18 years
• Not amenable to standard of care
• ECOG PS <=2
• Has documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours
• Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastasis
• Adequate organ function

You may not qualify if…

• Subjects with autoimmune disease or regular immunosuppressants
• Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD(L)1 antibody because of intolerable toxicity
• Has brain metastasis including leptomeningeal metastasis or primary brain tumour
• Has current or history of CNS disease
• Has known active infection
• Part 2B only - has prior treatment with anti PD(L)1 or anti CTLA4

Where it is running

• Sarah Cannon Research Institute, UK — London, United Kingdom (enrolling)
• Antoni van Leeuwenhoek — Amsterdam, North Holland, Netherlands (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• University Medical Center Groningen, — Groningen, Netherlands (enrolling)
• Erasmus University Medical Center Rotterdam — Rotterdam, Netherlands (enrolling)
• UMC Utrecht Cancer Center — Utrecht, Netherlands (enrolling)
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain (enrolling)
• hospital clinic de Barcelona — Barcelona, Spain (enrolling)
• hospital de la Sanat Creu i Sant Pau — Barcelona, Spain (enrolling)
• Clinica Universidad de Navarra — Madrid, Spain (enrolling)
• HU Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
• Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
• Hospital Universitario HM Sanchinarro — Madrid, Spain (enrolling)
• NEXT Oncology Hospital Quironsalud Madrid — Madrid, Spain (enrolling)
• HU Virgen de la Arrixaca — Murcia, Spain (enrolling)
• HU Virgen del Rocio - PPDS — Seville, Spain (enrolling)
• The Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (enrolling)
• Royal Marsden Hospital — London, Surrey, United Kingdom (enrolling)
• University College London Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
• VUMC Research B.V — Amsterdam, North Holland, Netherlands

Full record on ClinicalTrials.gov

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