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

• Status: Recruiting
• Trial end date: 2023-09-25
• Target enrollment: 0
• Participant gender: All

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 torelability to determine MTD and RP2D.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Crescendo Biologics Ltd.

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 0-1

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-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