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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Tri-specific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin
University of Washington
Seattle, Washington, United States
RECRUITINGNumber 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)
Time frame: 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
Time frame: 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.
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.
Time frame: 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
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.
Time frame: 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.
Time frame: anti-tumor response according to RECIST v1.1 or PCWG3 up to 20 months duration;
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Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
RECRUITINGVUMC Research B.V
Amsterdam, North Holland, Netherlands
WITHDRAWNUniversity Medical Center Groningen,
Groningen, Netherlands
RECRUITINGErasmus University Medical Center Rotterdam
Rotterdam, Netherlands
RECRUITINGUMC Utrecht Cancer Center
Utrecht, Netherlands
RECRUITINGClinica Universidad de Navarra
Pamplona, Navarre, Spain
RECRUITINGhospital clinic de Barcelona
Barcelona, Spain
RECRUITINGhospital de la Sanat Creu i Sant Pau
Barcelona, Spain
RECRUITINGClinica Universidad de Navarra
Madrid, Spain
RECRUITING...and 10 more locations
To measure how the body processes CB307 in the body over time
To evaluate the pharmacokinetic trough levels before administration of CB307
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: PSA response defined as a >50% decrease in PSA up to 20 months duration