Clinical trial · Interventional
A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions
A Phase I Study to Assess Biodistribution of 89Zr-CB307 in PSMA+ and PSMA- Tumour Lesions (A Sub-study of CBT307-1 Study - EUDRACT 2019-004584-46)
NCT05836623CI-TRIAL-00074518unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
CB307 is a trispecific Humabody® targeting CD137; PSMA; and human serum albumin (HSA) undergoing Phase 1 assessment in patients with PSMA+ solid tumours. This sub study will assess the biodistribution of radiolabelled CB307 in patients with advanced and/or metastatic solid tumours that are PSMA+.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced and/or Metastatic Solid Tumours | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CB307 | Drug | — | UNRESOLVED |
| Radiolabelled CB307 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A - Optimisation Phase
- description
- Following administration of 89Zr-CB307, patients will undergo PET scans The timing of the scans and CB307 dose administration will be determined by the Optimisation Review Committee (ORC)
- interventionNames
- Drug: Radiolabelled CB307
- Drug: CB307
- type
- EXPERIMENTAL
- label
- Part B - Expansion phase
- description
- 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC)
- interventionNames
- Drug: Radiolabelled CB307
- Drug: CB307
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of understanding the written informed consent. * Aged at least 18 years. * Not amenable to standard of care. * ECOG PS of 0 or 1. * 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 metastases. * Adequate organ function. * Willing to have a biopsy sample taken immediately after the last PET scan before initiation of the main study. Exclusion Criteria: * Subjects with autoimmune disease or regular immunosuppressants. * Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 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. * Biopsy cannot be safely obtained after the last PET scan, and not provided their consent.
References
Publications (0)
Data not yet available
No reference posted for this study.