Metastatic CancerPhase 1NCT06389123
Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
A Phase 1 study testing [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. in people with Metastatic Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- [68Ga]Ga DOTA-5G PET/CT Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 or more years
- Pathologically confirmed solid cancer with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis) or PERCIST.
- Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging.
- Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
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- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to [68Ga]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.
- Hematologic parameters defined as:
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
- Blood chemistry levels defined as:
- AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN
- Anticipated life expectancy ≥ 3 months
- Able to remain motionless for up to 30-60 minutes per scan
- [177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria:
- Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan
- The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal SUVmax >2-fold above normal tissue at site of metastasis e.g. normal lung, bone, brain) and identified on standard of care diagnostic imaging)
Who cannot join
- [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G therapy Exclusion Criteria:
- Participants with Class 3 or 4 NYHA Congestive Heart Failure
- Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
- Pregnant or lactating women
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
- Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
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- Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
- Psychiatric illness/social situations that would interfere with compliance with study requirements
- Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
- Pathologically confirmed NSCLC with metastatic disease
- INR >2.0: PTT>15 seconds above ULN
- Participant on therapeutic warfarin anticoagulation
- External beam radiation therapy (EBRT) or radiopharmaceutical treatment within 21 days prior to study day 1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Julie L Sutcliffe, PhD, 916-734-5536, jlsutcliffe@health.ucdavis.edu
About this study
Official title: A Novel Molecularly Targeted Theranostic Approach Via the αvβ6 Integrin for the Detection and Treatment of Metastatic Carcinomas
This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.
Read the detailed description
This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. [68Ga]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the [177Lu]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue.
The hypothesis are that a) [68Ga]Ga DOTA-5G will detect lesions in patients with metastatic cancer, b) the theranostic pair [68Ga]Ga DOTA-5G/ [177Lu]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of [177Lu]Lu DOTA-ABM-5G.
- Conditions
- Metastatic Cancer
- Being tested
- [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
- Keywords
- integrin, PET, Theranostics, metastatic cancer
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.Drug
Also called [68Ga]Ga DOTA-5G, [177Lu]Lu DOTA-ABM-5G, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair
Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up [68Ga]Ga DOTA-5G PET/CT scans to assess tretament efficacy.
| Study group | Role | What they receive |
|---|---|---|
| [177Lu]Lu DOTA-ABM-5G single dose therapy study | Experimental | Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy. Receives: Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. |
What is being measured
The primary outcome is the main question the study is designed to answer.
[68Ga]Ga DOTA-5G PET/CT imaging
To assess the ability of [68Ga]Ga DOTA-5G to detect lesions in patients with metastatic cancer
Measured: 2 hours from time of injection
Secondary outcomes (2)
[177Lu]Lu DOTA-ABM-5G treatment
To assess the safety and tolerability of a single treatment with [177Lu]Lu DOTA-ABM-5G
Measured: 30 days from time of treatment
[177Lu]Lu DOTA-ABM-5G treatment efficacy
To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second [68Ga]Ga DOTA-5G PET/CT, prior to next line of therapy.
Measured: 60 days from time of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single treatment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Julie L. Sutcliffe, Ph.D, University of California, Davis
- Investigators
- Julie L Sutcliffe, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389123
- Sponsor's protocol ID
- 1788760
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2024
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Molecularly Targeted Theranostic Approach Via the αvβ6 Integrin for the Detection and Treatment of Metastatic Carcinomas
- ClinicalTrials.gov ID
- NCT06389123
- Acronym / sponsor ID
- 1788760
- Conditions
- Metastatic Cancer
- Keywords
- integrin, PET, Theranostics, metastatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Apr 2024 (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 a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.
Detailed description
This is a Phase I study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. [68Ga]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the [177Lu]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue.
The hypothesis are that a) [68Ga]Ga DOTA-5G will detect lesions in patients with metastatic cancer, b) the theranostic pair [68Ga]Ga DOTA-5G/ [177Lu]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of [177Lu]Lu DOTA-ABM-5G.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single treatment
| Arm | Type | Receives |
|---|---|---|
| [177Lu]Lu DOTA-ABM-5G single dose therapy study | Experimental | Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 or more years
- Pathologically confirmed solid cancer with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis) or PERCIST.
- Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging.
- Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
Key exclusion criteria (13 listed)
- Participants with Class 3 or 4 NYHA Congestive Heart Failure
- Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
- Pregnant or lactating women
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
- Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
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 |
|---|---|---|
| [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.Also: [68Ga]Ga DOTA-5G, [177Lu]Lu DOTA-ABM-5G, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pairPatients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up [68Ga]Ga DOTA-5G PET/CT scans to assess tretament efficacy. | Drug | [177Lu]Lu DOTA-ABM-5G single dose therapy study |
Primary outcome
[68Ga]Ga DOTA-5G PET/CT imaging
Time frame: 2 hours from time of injection
To assess the ability of [68Ga]Ga DOTA-5G to detect lesions in patients with metastatic cancer
2 secondary outcomes
[177Lu]Lu DOTA-ABM-5G treatment
Time frame: 30 days from time of treatment
[177Lu]Lu DOTA-ABM-5G treatment efficacy
Time frame: 60 days from time of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
Julie L Sutcliffe principal investigator
University of California, Davis
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 [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. in people with Metastatic Cancer, run by University of California, Davis at 1 site in United States.
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 17 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie L Sutcliffe, Phd (9167345536, jlsutcliffe@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[68Ga]Ga DOTA-5G PET/CT imaging (time frame: 2 hours from time of injection). 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 11 Sep 2026.