Overview
Sponsor-declared trial summary
Breast cancer
Primary objectives: To measure the spatial correlation of PET uptake of [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab in tumors and T-cell rich organs such as lymph nodes prior to resection. To measure the strength of correlation between the presence of CD8+ cells and T cell activation features in the resected tumor and…
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 May 2024 → ongoing
- Decision date (initial)
- 2024-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Foundation for National Institutes of Health (FNIH)
External identifiers
- EU CT number
- 2023-509486-20-00
- ClinicalTrials.gov
- NCT06457789
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Primary objectives:
To measure the spatial correlation of PET uptake of [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab in tumors and T-cell rich organs such as lymph nodes prior to resection.
To measure the strength of correlation between the presence of CD8+ cells and T cell activation features in the resected tumor and lymph nodes with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG, respectively.
Secondary objectives 1
- Secondary objective: To measure the strength of correlation of pathological response (i.e., the percentage of residual viable tumor cells) in the resected tumor with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG, respectively.
Conditions and MedDRA coding
Breast cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- To be eligible to participate in this study, a patient must meet all of the following criteria: 1. Histologically confirmed NSCLC, melanoma, esophageal or triple negative breast cancer 2. Lesion size of ≥2cm, at time of the (re)staging FDG PET/CT 3. Planned to undergo resection according to routine treatment guidelines 4. Neoadjuvant chemotherapy + IO is allowed 5. Willing and able to provide written informed consent for the trial 6. Above 18 years of age on day of signing informed consent 7. Have measurable disease based on RECIST 1.15 8. Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing
Exclusion criteria 1
- A patient who meets any of the following criteria will be excluded from participation in this study: 1. Patients deemed inoperable 2. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Main trial endpoints and their analysis: The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method. The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.
Secondary endpoints 1
- Secondary trial endpoints and their analysis: The Pearson correlation coefficient between each tracer tumor uptake and percentage of residual viable tumor cells (VTC) in regions of concordance and discordance and the maximal VTC of the whole of the tumor. The Pearson correlation coefficient between each tracer uptake and the T cell features in resected lymph nodes (if present).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9954028 · Product
- Active substance
- Zirconium (89ZR) Crefmirlimab Berdoxam
- Substance synonyms
- Zirconium Zr 89 crefmirlimab berdoxam, 89Zr-Df-IAB22M2C, Minibody against CD8 conjugated to desferrioxamine labeled with zirconium Zr 89, 89Zr-desferrioxamine-IAB22M2C, RO7499775
- Other product name
- Zirconium Zr 89 crefmirlimab berdoxam
- Pharmaceutical form
- AQUEOUS SOLUTION FOR INTRAVENOUS (IV) ADMINISTRATION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 33 MBq megabecquerel(s)
- Max total dose
- 41 MBq megabecquerel(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- IMAGINAB, INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB09188MIG · Substance
- Active substance
- Nelarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 166 MBq megabecquerel(s)
- Max total dose
- 204 MBq megabecquerel(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Modified into radiopharmaceutical tracer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- Idris Bahce
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Idris Bahce
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 34 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-05-29 | 2024-12-04 | 2026-01-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_iRelate Clinical Trial Protocol iRelate 2023-509486-20-00 | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements iRelate | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_participants iRelate AUMC | 1.4 |
| Summary of Product Characteristics (SmPC) (for publication) | Not Applicable | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Not Applicable | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Dutch iRelate 2023-509486-20-00 | 2.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Netherlands | Acceptable 2024-05-22
|
2024-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-04 | Netherlands | Acceptable 2025-01-30
|
2025-01-30 |