Treatment of advanced PSMA-positive tumors with CB307
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
This study is testing a new treatment called CB307 for people with advanced prostate cancer to see if it can help them feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Crescendo Biologics Ltd. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 20 sites (Seattle, Washington and 19 other locations) |
| Trial ID | NCT04839991 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open-label, multi-center study evaluating CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA-positive solid tumors. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD) and a cohort expansion phase assessing the safety and efficacy of CB307 alone and in combination with pembrolizumab for patients with metastatic castration-resistant prostate cancer. Approximately 70 patients will participate, receiving treatment until loss of clinical benefit or unacceptable toxicity occurs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed PSMA-positive advanced or metastatic solid tumors who are not amenable to standard care.
Not a fit: Patients with autoimmune diseases, brain metastases, or those who have previously experienced intolerable toxicity from certain immunotherapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced PSMA-positive tumors who have limited standard care options.
How similar studies have performed: While this approach is novel, similar studies targeting PSMA-positive tumors have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Seattle, Washington and 19 other locations
- University of Washington — Seattle, Washington, United States (Recruiting)
- Antoni van Leeuwenhoek — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- VUMC Research B.V — Amsterdam, Noord-Holland, Netherlands (Withdrawn)
- University Medical Center Groningen, — Groningen, Netherlands (Recruiting)
- Erasmus University Medical Center Rotterdam — Rotterdam, Netherlands (Recruiting)
- UMC Utrecht Cancer Center — Utrecht, Netherlands (Recruiting)
- Clinica Universidad de Navarra — Pamplona, Navarra, Spain (Recruiting)
- hospital clinic de Barcelona — Barcelona, Spain (Recruiting)
- hospital de la Sanat Creu i Sant Pau — Barcelona, Spain (Recruiting)
- Clinica Universidad de Navarra — Madrid, Spain (Recruiting)
- HU Fundacion Jimenez Diaz — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario HM Sanchinarro — Madrid, Spain (Recruiting)
- NEXT Oncology Hospital Quironsalud Madrid — Madrid, Spain (Recruiting)
- HU Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- HU Virgen del Rocio - PPDS — Sevilla, Spain (Recruiting)
- The Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
- Royal Marsden Hospital — London, Surrey, United Kingdom (Recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- Sarah Cannon Research Institute, UK — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Md
- Email: Clinicaltrials@crescendobiologics.com
- Phone: 01223497140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.