RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-06-08
Study Completion:2024-09-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04839991

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Capable of understanding the written informed consent
  2. 2. Aged at least 18 years
  3. 3. Not amenable to standard of care
  4. 4. ECOG PS \<=2
  5. 5. Has documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours
  6. 6. Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastasis
  7. 7. Adequate organ function
  1. 1. Subjects with autoimmune disease or regular immunosuppressants
  2. 2. Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD(L)1 antibody because of intolerable toxicity
  3. 3. Has brain metastasis including leptomeningeal metastasis or primary brain tumour
  4. 4. Has current or history of CNS disease
  5. 5. Has known active infection
  6. 6. Part 2B only - has prior treatment with anti PD(L)1 or anti CTLA4

Contacts and Locations

Study Contact

MD
CONTACT
01223497140
Clinicaltrials@crescendobiologics.com
MD
CONTACT
012234947140
info@crescendobiologics.com

Principal Investigator

K Hashimoto
STUDY_DIRECTOR
Crescendo Biologics

Study Locations (Sites)

University of Washington
Seattle, Washington, 98109-5311
United States

Collaborators and Investigators

Sponsor: Crescendo Biologics Ltd.

  • K Hashimoto, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2021-06-08
Study Completion Date2024-09-25

Study Record Updates

Study Start Date2021-06-08
Study Completion Date2024-09-25

Terms related to this study

Keywords Provided by Researchers

  • 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
  • Pembrolizumab
  • KEYTRUDA®

Additional Relevant MeSH Terms

  • Advanced and/or Metastatic Solid Tumours