Advanced and/or Metastatic Solid TumoursPhase 1NCT05836623
A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions
A Phase 1 study testing Radiolabelled CB307 and CB307 in people with Advanced and/or Metastatic Solid Tumours, run by Crescendo Biologics Ltd. at 1 site in Netherlands.
Trial 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+. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced and/or Metastatic Solid Tumours
- What is being tested?
- Radiolabelled CB307 and CB307
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Dec 2022to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen,
Groningen, P.O. Box 30 001
About this study
Official title: 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)
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+.
Read the 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.
- Conditions
- Advanced and/or Metastatic Solid Tumours
- Being tested
- Radiolabelled CB307, CB307
- Keywords
- Phase 1 Study, Solid Tumours, Castration-resistant prostate cancer (CRPC), Prostate Specific Membrane Antigen (PSMA), Crescendo Biologics, CD137, CB307, Humabody®, Radiolabelled CB307, 89-Zirconium, Biodistribution, HSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabelled CB307Drug
Also called 89Zr-CB307
CB307 radiolabelled with 89-Zirconium (89Zr CB307): drug product is formulated at a concentration of 1 mg/mL (37 MBq)
CB307Drug
Trispecific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin
| Study group | Role | What they receive |
|---|---|---|
| Part A - Optimisation Phase | Experimental | 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) Receives: Drug: Radiolabelled CB307; Drug: CB307 |
| Part B - Expansion phase | Experimental | 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC) Receives: Drug: Radiolabelled CB307; Drug: CB307 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307.
Incidence (frequency and severity) of adverse events following administration of 89Zr-CB307 assessed by CTCAE version 5.0
Measured: Throughout study completion, up to 8 months from first patient recruited.
Assessment of 89Zr-CB307 uptake by PET scan by measuring maximum standardized uptake value in the tumour lesions.
SUVpeak - maximum standardized uptake value.
Measured: Throughout study completion, up to 8 months from first patient recruited.
Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions.
SUVmean - mean standardized uptake value.
Measured: Throughout study completion, up to 8 months from first patient recruited.
Assessment of 89Zr-CB307 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the tumour lesions.
%ID/g - percentage of injected dose per gram.
Measured: Throughout study completion, up to 8 months from first patient recruited.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start20 Dec 2022
- Primary completion31 Jan 2024
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and/or Metastatic Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Following administration of 89Zr-CB307, enrolled patients will undergo a number of PET scans where uptake of the radiolabelled drug will be assessed
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crescendo Biologics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Julia Tilson, Study director, Crescendo Biologics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836623
- Sponsor's protocol ID
- CBT307-1-RL
- Other IDs
- 2021-006256-13
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05836623
- Acronym / sponsor ID
- CBT307-1-RL
- Conditions
- Advanced and/or Metastatic Solid Tumours
- Keywords
- Phase 1 Study, Solid Tumours, Castration-resistant prostate cancer (CRPC), Prostate Specific Membrane Antigen (PSMA), Crescendo Biologics, CD137, CB307, Humabody®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Crescendo Biologics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Groningen
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following administration of 89Zr-CB307, enrolled patients will undergo a number of PET scans where uptake of the radiolabelled drug will be assessed
| Arm | Type | Receives |
|---|---|---|
| Part A - Optimisation Phase | Experimental | Drug: Radiolabelled CB307, Drug: CB307Following 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 | Experimental | Drug: Radiolabelled CB307, Drug: CB30789Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiolabelled CB307Also: 89Zr-CB307CB307 radiolabelled with 89-Zirconium (89Zr CB307): drug product is formulated at a concentration of 1 mg/mL (37 MBq) | Drug | Part A - Optimisation Phase, Part B - Expansion phase |
| CB307Trispecific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin | Drug | Part A - Optimisation Phase, Part B - Expansion phase |
Primary outcome
Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307.
Time frame: 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.
Time frame: Throughout study completion, up to 8 months from first patient recruited.
SUVpeak - maximum standardized uptake value.
Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions.
Time frame: 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.
Time frame: Throughout study completion, up to 8 months from first patient recruited.
%ID/g - percentage of injected dose per gram.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Tilson study director
Crescendo Biologics Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiolabelled CB307 and CB307 in people with Advanced and/or Metastatic Solid Tumours, run by Crescendo Biologics Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307. (time frame: Throughout study completion, up to 8 months from first patient recruited.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.