Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests the safety of a radioactive scan drug, [68Ga]Ga DOTA-5G, and a radioactive treatment, [177Lu]Lu DOTA-ABM-5G, and how well they work. It is for adults with non-small cell lung cancer that has spread and gotten worse during or after at least one approved drug treatment.
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 non small cell lung cancer (NSCLC).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and able and willing to sign a consent form.
- Have non-small cell lung cancer confirmed by a tissue test that has spread. Have at least one tumor larger than 1 cm or a lymph node larger than 1.5 cm across its shorter side.
- Scans must show that the cancer got worse during or after at least one FDA-approved treatment that works throughout the body. Have a stored tumor sample available.
- Be able to care for yourself and be out of bed or a chair for at least half the day. Be expected to live at least 3 months.
- Finish prior drug treatment at least 2 weeks before the study scan. Major side effects must be mild or back to their usual level, except hair loss or nerve damage that affects feeling.
- Meet the study's blood cell count, liver, kidney, and blood chemistry limits.
- Be able to lie still for 30–60 minutes for each scan.
- For the radioactive treatment, first complete the study PET/CT scan. At least one measurable cancer spot must take up more than twice as much scan drug as normal tissue and also appear on a standard scan.
Who can't join
- Have severe heart failure.
- Have major bleeding within the past 2 weeks, or blood-clotting tests outside the study's limits.
- Be pregnant or breastfeeding.
- Have major surgery with general anesthesia and a large cut within 28 days before the study starts, or expect surgery in the next 6 weeks.
- Have another active cancer needing treatment within the past 2 years. Exceptions include certain early skin cancers removed by surgery and breast or cervical cancers that have not spread beyond where they started.
- Have an active infection that remains uncontrolled despite treatment, or a mental health or social problem that would prevent following study requirements.
- Be unable to have the study scans because of the 350-pound weight limit.
- Have interstitial lung disease or pulmonary fibrosis, conditions that damage or scar the lungs.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: \[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 or more years 3. Pathologically confirmed NSCLC 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) 4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen as established by diagnostic imaging. 5. Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available. 6. Eastern Cooperative Oncology Group Performance Status ≤ 2 7. 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. 8. Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL 9. 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 10. Anticipated life expectancy ≥ 3 months 11. Able to remain motionless for up to 30-60 minutes per scan \[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria: 1. Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan 2. The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain MRI as per standard of care for patients with metastatic NSCLC. Exclusion Criteria: \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria: 1. Participants with Class 3 or 4 NYHA Congestive Heart Failure 2. Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding) 3. Pregnant or lactating women 4. 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 5. 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) 6. Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy 7. Psychiatric illness/social situations that would interfere with compliance with study requirements 8. Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.) 9. Known interstitial lung disease or pre-existing pulmonary fibrosis 10. INR \>2.0: PTT\>15 seconds above ULN
Study sites (1)
CA
- The University of California Davis Comprehensive Cancer Center · Sacramento, CA 95817Julie L Sutcliffe, PhD · Study contact · 916-734-5536 · jlsutcliffe@ucdavis.eduMegan Daly, MD · Sub-investigatorMore trials in Sacramento