To assess the safety of 89ZrCB307To assess 89Zr-CB307 uptake by PET scan
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•To assess the safety of 89Zr-CB307: Incidence (frequency and severity) of
adverse events occurring following administration of 89Zr-CB307 assessed by
CTCAE ver 5.0;
•To assess 89Zr-CB307 uptake by PET scan: SUVpeak - maximum standardised uptake
value; SUVmean - mean standardised uptake value; Percentage of Injected Dose
per Gram of Tissue (%ID/g) in the tumour.
Secondary outcome
During the conduct of the sub-study, multiple PET scans will be performed and
safety assessments for the evaluation of the safety profile will be done. In
addition, safety laboratory parameters and electrocardiogram (ECG) data will be
evaluated using data after completion of the sub-study and prior to commencing
C1D1 of the main study. Any AEs or SAEs that occur during the screening period
or the sub-study will be followed up until resolution. If the AE is not
resolved at the time of completion of the sub-study or by the required
follow-up period of the sub-study, these data will be reported in the main
study.
Background 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+.
Study objective
To assess the safety of 89ZrCB307
To assess 89Zr-CB307 uptake by PET scan
Study design
Following administration of 89Zr-CB307, enrolled patients will undergo a number
of PET scans where uptake of the radiolabelled drug will be assessed and a
post-treatment tumour biopsy (for assessment of PSMA expression) will 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, following administration of 89Zr-CB307, patients will undergo PET
scans (a maximum of 3 post-tracer PET scans). The timing of the scans and
post-dose tumour biopsy and level of CB307 cold dose to be administered will be
determined by the Optimisation Review Committee (ORC)
In Part B (Expansion Phase), 89Zr-CB307 PET scanning will be performed up to a
maximum of 2 times based on the optimal dosing and timing determined in Part A
by the ORC
Intervention
Radio-labeled CB307
Study burden and risks
There is no clinical data available for CB307 to date. Preclinical studies
suggest that activation CD137-positive T cells is observed with CB307 in the
presence of PSMA-expressing tumours. Hepatotoxicity observed in urelumab may be
mitigated, as CB307 does not contain an Fc region and does not induce
nonspecific macrophage activation. In addition, the starting dose of the first
in human study is selected carefully based on the toxicology and pharmacology
studies. Based on the preliminary result of PRS343, a CD137 targeting
bispecific agent and the results of AMG212 and HPN424, both PSMA-and CD3
targeting bispecific molecules, CB307 may demonstrate efficacy in a clinical
trial with an acceptable safety profile and it is considered that the potential
benefits outweigh the potential risks
Meditrina Building, Babraham Research Campus 260
Cambridge CB22 3AT
GB
Meditrina Building, Babraham Research Campus 260
Cambridge CB22 3AT
GB
Listed location countries
Age
Inclusion criteria
1. Is capable of understanding the written informed consent form (ICF),
provides signed and witness informed consent and agrees to comply with protocol
requirements
2. Is aged at least 18 years at the time of signing the ICF
3. Has a documented, histologically-confirmed diagnosis of advanced or
metastatic solid tumours
See protocol page 26 for the full list of inclusion criteria)
Note: Subject must qualify for the main study and must have met the relevant
inclusion and exclusion criteria and signed the ICF for the main study (see
also section J)
Exclusion criteria
1. Has evidence of autoimmune or significant, uncontrolled concomitant diseases
that could affect compliance with the protocol or interpretation of the results
2. Has discontinued from anti-cytotoxic lymphocyte-associated protein 4,
anti-programmed cell death protein 1, or anti-programmed cell death ligand 1
antibody because of intolerable toxicity according to the investigator*s
assessment.
3. Has brain metastasis, including leptomeningeal metastasis or a primary brain
tumour.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-006256-13-NL |
| CCMO | NL82094.042.22 |