A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions
- Conditions
- Advanced and/or Metastatic Solid Tumours
- Interventions
- Drug: Radiolabelled CB307
- Registration Number
- NCT05836623
- Lead Sponsor
- Crescendo Biologics Ltd.
- Brief Summary
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+.
- Detailed Description
Phase 1, Open-label, single centre, non-randomised study during which, enrolled patients will undergo a number of PET scans following administration of 89Zr-CB307, in order to assess the uptake of the radiolabelled drug. A post-treatment tumour biopsy for the assessment of PSMA expression will also be taken, if medically feasible, after the last PET scan.
The sub-study consists of 2 parts: an Optimisation Phase (Part A) and an Expansion Phase (Part B).
In Part A, both 89Zr-CB307 and CB307 will be administered to patients. The timing of the scans, post-dose tumour biopsy and CB307 dose will be optimised as determined by the Optimisation Review Committee (ORC).
In Part B (Expansion Phase), 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A.
The sub-study will continue for 7 days after the tracer injection. Patients will then be enrolled into the main study and will receive Cycle 1 Day 1 (C1D1) CB307 treatment according to the main study protocol.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part B - Expansion phase Radiolabelled CB307 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC) Part A - Optimisation Phase Radiolabelled CB307 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) Part A - Optimisation Phase CB307 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) Part B - Expansion phase CB307 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC)
- Primary Outcome Measures
Name Time Method Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions. Throughout study completion, up to 8 months from first patient recruited. SUVmean - mean standardized uptake value.
Assessment of 89Zr-CB307 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the tumour lesions. Throughout study completion, up to 8 months from first patient recruited. %ID/g - percentage of injected dose per gram.
Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307. Throughout study completion, up to 8 months from first patient recruited. Incidence (frequency and severity) of adverse events following administration of 89Zr-CB307 assessed by CTCAE version 5.0
Assessment of 89Zr-CB307 uptake by PET scan by measuring maximum standardized uptake value in the tumour lesions. Throughout study completion, up to 8 months from first patient recruited. SUVpeak - maximum standardized uptake value.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Medical Center Groningen,
🇳🇱Groningen, Netherlands