Status:
UNKNOWN
Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
Lead Sponsor:
Crescendo Biologics Ltd.
Conditions:
Advanced and/or Metastatic Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 det...
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 patie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04839991
Start Date
June 8 2021
End Date
September 25 2024
Last Update
November 18 2023
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington
Seattle, Washington, United States, 98109-5311
2
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066 CX
3
VUMC Research B.V
Amsterdam, North Holland, Netherlands, 1081 HV
4
University Medical Center Groningen,
Groningen, Netherlands, P.O. Box 30 001