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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839991
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Crescendo Biologics Ltd.

Study Description
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Brief Summary:
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 RP2D.

Condition or disease Intervention/treatment Phase
Advanced and/or Metastatic Solid Tumours Drug: CB307 Phase 1

Detailed Description:
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. The study will consist of a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) which will consist of 2 arms. Approximately 70 patients will participate in total. Patients will receive CB307 IV, 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Initial dose escalation cohorts followed by a single dose expansion cohort. The cohort expansion phase will consist of 2 arms.
Masking: None (Open Label)
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 : June 8, 2021
Estimated Primary Completion Date : July 25, 2023
Estimated Study Completion Date : September 25, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A
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.
 Drug: CB307
Tri-specific Humabody targeting CD137, prostate specific membrane antigen and human serum albumin
Experimental: Multi center open label Dose Escalation followed by Cohort Expansion: Part 2B
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 2B arm will enrol patients with PSMA+ metastatic, castration resistant prostate cancer patients with mutations of sponsor interest. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months.
 Drug: CB307
Tri-specific Humabody targeting CD137, prostate specific membrane antigen and human serum albumin


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ 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. ]
    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)


Secondary Outcome Measures :
  1. To evaluate clinical efficacy measured as progression-free survival according to RECIST v.1.1 or PCWG3 [ 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 measure how well the treatment succeeds in producing the desired effect.

  2. To measure how the body processes CB307 in the body over time [ Time Frame: PK parameters of CB307: data collected at time point 0 at each dosing period up to 20 months duration. ]
    To evaluate the pharmacokinetic trough levels before administration of CB307

  3. Pharmacokinetic of CB307 T1/2 [ Time Frame: Data collected up to 20 months duration. ]
    To evaluate the pharmacokinetic T1/2 after 3rd dose via IV for multiple dose levels of CB307

  4. Pharmacokinetic of CB307 Tmax [ Time Frame: Data collected up to 20 months duration. ]
    To evaluate the pharmacokinetic Tmax after 3rd dose via IV for multiple dose levels of CB307

  5. To measure Tumour Immune response [ Time Frame: Tumor response per RECIST ver 1.1 up to 20 months duration ]
    To determine the potential of CB307 to produce an immune response and assess the relationship with other outcome measures

  6. Relationship of CB307 to anti tumour response [ Time Frame: PSA response defined as a >50% decrease in PSA up to 20 months duration ]
    To evaluate the preliminary CB307 dose in relationship to activity of changes in tumour


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Capable of understanding the written informed consent
  2. Aged at least 18 years
  3. Not amenable to standard of care
  4. ECOG PS <=2
  5. Has documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours
  6. Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastasis
  7. Adequate organ function
  8. Cohort Expansion phase - Part 2B arm patients only: Has known mutations of sponsor interest

Exclusion Criteria:

  1. Subjects with autoimmune disease or regular immunosuppressants
  2. Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity
  3. Has brain metastasis including leptomeningeal metastasis or primary brain tumour
  4. Has current or history of CNS disease
  5. Has known active infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839991


Contacts
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Contact: MD 01223497140 Clinicaltrials@crescendobiologics.com
Contact: J Tilson 07725 844778 jtilson@crescendobiologics.com

Locations
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Netherlands
Antoni van Leeuwenhoek Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Contact: MD       f.opdam@nki.nl   
VUMC Research B.V Withdrawn
Amsterdam, Noord-Holland, Netherlands, 1081 HV
University Medical Center Groningen, Recruiting
Groningen, Netherlands, P.O. Box 30 001
Contact: MD       e.g.e.de.vries@umcg.nl   
Principal Investigator: Elisabeth De Vries         
Erasmus University Medical Center Rotterdam Recruiting
Rotterdam, Netherlands
Contact: MD       m.lolkema@erasmusmc.nl   
UMC Utrecht Cancer Center Recruiting
Utrecht, Netherlands, 3584 CX
Contact: MD       E.H.Gort-2@umcutrecht.nl   
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Ignacio Melero       imelero@unav.es   
Principal Investigator: Ignacio Melero         
Clinica Universidad de Navarra Recruiting
Madrid, Spain, 28027
Contact: Ignacio Melero       imelero@unav.es   
Principal Investigator: Ignacio Melero         
HU Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Bernard Doger de Speville Uribe       bernard.doger@startmadrid.com   
Principal Investigator: Bernard Doger de Speville Uribe         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Daniel Castellano       cdanicas@hotmail.com   
Principal Investigator: Daniel Castellano         
Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Irene Moreno       irene.moreno@startmadrid.com   
Principal Investigator: Irene Moreno         
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: MD       fiona.thistlethwaite@christie.nhs.uk   
Principal Investigator: Fiona Thistlethwaite         
The Clatterbridge Cancer Centre NHS Foundation Trust Withdrawn
Bebington, Merseyside, United Kingdom, CH63 4JY
Royal Marsden Hospital Recruiting
London, Surrey, United Kingdom, SM2 5PT
Contact: MD       Johann.DeBono@icr.ac.uk   
Principal Investigator: Johann De Bono         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2BU
Contact: Anya Williams       Anja.Williams@hcahealthcare.co.uk   
Principal Investigator: Anya Williams         
Sarah Cannon Research Institute, UK Recruiting
London, United Kingdom, W1G 6AD
Contact: Anuradha Jayaram       a.jayaram@ucl.ac.uk   
Principal Investigator: Anuradha Jayaram         
Sponsors and Collaborators
Crescendo Biologics Ltd.
Investigators
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Study Director: J Tilson Crescendo Biologics
More Information
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Responsible Party: Crescendo Biologics Ltd.
ClinicalTrials.gov Identifier: NCT04839991    
Other Study ID Numbers: CBT307-1
2019-004584-46 ( EudraCT Number )
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crescendo Biologics Ltd.:
Prostate Specific Membrane Antigen (PSMA)
Solid Tumours
Castration-resistant prostate cancer (CRPC)
First in Human (FIH)
Phase 1 Study
CD137
 4-1BB
Crescendo Biologics
CB307
Humabody
HSA
Additional relevant MeSH terms:
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Neoplasms