HER2-positive Solid TumorPhase 2NCT04757090
89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
A Phase 2 study testing 89Zr-trastuzumab in people with HER2-positive Solid Tumor and HER-2 Positive Cancer, run by Washington University School of Medicine.
Trial summary
This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Solid Tumor, HER-2 Positive Cancer
- What is being tested?
- 89Zr-trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 31 Dec 2023
- Phase
- Phase 2
- 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
- Must meet eligibility criteria and be registered to receive treatment under Protocol MT-5111_001 (WU HRPO # 201907092).
- Must have at least one measurable lesion by RECIST 1.1 during the dose expansion phase of MT-5111_001. Osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included.
- Must have standard of care 18F-FDG-PET/CT within 90 days before administration of 89Zr-trastuzumab OR be willing to undergo 18F-FDG PET/CT scan for research purposes.
- Able to undergo PET/CT imaging
- Able to understand and willing to sign an IRB-approved written informed consent document.
Who cannot join
- Hepatic only disease
- Pregnant or breastfeeding.
About this study
Official title: A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111
- Conditions
- HER2-positive Solid Tumor, HER-2 Positive Cancer
- Being tested
- 89Zr-trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-trastuzumabDrug
-To minimize uptake of the 89Zr-trastuzumab in normal tissues, immediately prior to planned 89Zr-trastuzumab injection patients will receive a 50 mg dose of "cold" unlabeled trastuzumab intravenously (IV). The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-trastuzumab PET/CT imaging | Experimental | * Enrolled subjects will be asked to undergo 18F-FDG PET/CT imaging (if not performed within the previous 90 days) and 89Zr-trastuzumab PET/CT imaging at baseline prior to the start of monotherapy MT-5111 treatment. Standard of care 18F-FDG PET/CT examinations performed within 90 days of 89Zr-trastuzumab administration can be used in place of a study specific 18F-FDG PET/CT scan. Baseline 89Zr-trastuzumab imaging should be completed no more than 30 days prior to initiating treatment with MT-5111.
* Cold trastuzumab and 89Zr-trastuzumab will be administered at Visit 1 and the 89Zr-trastuzumab PET/CT (Visit 2) will take place 4 days (+/-1 day) after administration of 89Zr-trastuzumab. Receives: Drug: 89Zr-trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT
-SUVmax is maximum standardized uptake value
Measured: At baseline
Secondary outcomes (3)
Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT
Measured: At baseline
Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT
Measured: At baseline
Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start31 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Solid TumorStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular Templates, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian A Van Tine, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757090
- Sponsor's protocol ID
- 202103039
- Status last verified
- Dec 2021
- First submitted
- 15 Feb 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
- ClinicalTrials.gov ID
- NCT04757090
- Acronym / sponsor ID
- 202103039
- Conditions
- HER2-positive Solid Tumor, HER-2 Positive Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Molecular Templates, Inc.
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Feb 2021 (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.
This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-trastuzumab PET/CT imaging | Experimental | Drug: 89Zr-trastuzumab* Enrolled subjects will be asked to undergo 18F-FDG PET/CT imaging (if not performed within the previous 90 days) and 89Zr-trastuzumab PET/CT imaging at baseline prior to the start of monotherapy MT-5111 treatment. Standard of care 18F-FDG PET/CT examinations performed within 90 days of 89Zr-trastuzumab administration can be used in place of a study specific 18F-FDG PET/CT scan. Baseline 89Zr-trastuzumab imaging should be completed no more than 30 days prior to initiating treatment with MT-5111. * Cold trastuzumab and 89Zr-trastuzumab will be administered at Visit 1 and the 89Zr-trastuzumab PET/CT (Visit 2) will take place 4 days (+/-1 day) after administration of 89Zr-trastuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must meet eligibility criteria and be registered to receive treatment under Protocol MT-5111_001 (WU HRPO # 201907092).
- Must have at least one measurable lesion by RECIST 1.1 during the dose expansion phase of MT-5111_001. Osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included.
- Must have standard of care 18F-FDG-PET/CT within 90 days before administration of 89Zr-trastuzumab OR be willing to undergo 18F-FDG PET/CT scan for research purposes.
- Able to undergo PET/CT imaging
- Able to understand and willing to sign an IRB-approved written informed consent document.
Key exclusion criteria (2 listed)
- Hepatic only disease
- Pregnant or breastfeeding.
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 |
|---|---|---|
| 89Zr-trastuzumab-To minimize uptake of the 89Zr-trastuzumab in normal tissues, immediately prior to planned 89Zr-trastuzumab injection patients will receive a 50 mg dose of "cold" unlabeled trastuzumab intravenously (IV). The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure. | Drug | 89Zr-trastuzumab PET/CT imaging |
Primary outcome
Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT
Time frame: At baseline
-SUVmax is maximum standardized uptake value
3 secondary outcomes
Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT
Time frame: At baseline
Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT
Time frame: At baseline
Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for HER2-positive Solid Tumor
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
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.
Brian A Van Tine, M.D., Ph.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 89Zr-trastuzumab in people with HER2-positive Solid Tumor and HER-2 Positive Cancer, run by Washington University School of Medicine.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT (time frame: At baseline). 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 23 Dec 2021.