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

November 16, 2023 updated by: Crescendo Biologics Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (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

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, P.O. Box 30 001
        • Recruiting
        • University Medical Center Groningen,
        • Contact:
        • Principal Investigator:
          • Elisabeth De Vries
      • Rotterdam, Netherlands
      • Utrecht, Netherlands, 3584 CX
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Withdrawn
        • VUMC Research B.V
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
      • Barcelona, Spain, 08041
        • Recruiting
        • hospital de la Sanat Creu i Sant Pau
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Daniel Castellano
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
        • Principal Investigator:
          • Ignacio Melero
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario Hm Sanchinarro
        • Contact:
        • Principal Investigator:
          • Irene Moreno
      • Madrid, Spain, 28040
        • Recruiting
        • HU Fundacion Jimenez Diaz
        • Contact:
        • Principal Investigator:
          • Bernard Doger de Speville Uribe
      • Madrid, Spain, 28050
        • Recruiting
        • NEXT Oncology Hospital Quironsalud Madrid
        • Contact:
      • Murcia, Spain, 30120
      • Sevilla, Spain, 41013
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
        • Principal Investigator:
          • Ignacio Melero
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Anuradha Jayaram
        • Contact:
      • London, United Kingdom, W1G 6AD
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
    • Surrey
      • London, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
        • Principal Investigator:
          • Johann de Bono
  • United States
    • Washington
      • Seattle, Washington, United States, 98109-5311
        • Recruiting
        • University of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  1. Subjects with autoimmune disease or regular immunosuppressants
  2. Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD(L)1 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
  6. Part 2B only - has prior treatment with anti PD(L)1 or anti CTLA4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Combination Cohort Expansion : Part 2B
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.
Drug: CB307
Tri-specific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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
PK parameters of CB307: data collected at time point 0 at each dosing period up to 20 months duration.
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
Data collected up to 20 months duration.
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
Data collected up to 20 months duration.
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
Tumor response per RECIST ver 1.1 up to 20 months duration
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
PSA response defined as a >50% decrease in PSA up to 20 months duration
To evaluate clinical efficacy and duration of response by radiographic progression free survival (rPFS)
Time Frame: radiographic progression free survival up to 20 months duration;
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
Time Frame: anti-tumor response according to RECIST v1.1 or PCWG3 up to 20 months duration;
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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crescendo Biologics Ltd.

Investigators

  • Study Director: K Hashimoto, Crescendo Biologics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Estimated)

July 25, 2024

Study Completion (Estimated)

September 25, 2024

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT307-1
  • 2019-004584-46 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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