Search / Trial NCT06228482

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Jan 18, 2024

Apply for Trial

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Integrin Metastatic Nsclc Pet Theranostic

ClinConnect Summary

This clinical trial is studying a new treatment for patients with metastatic non-small cell lung cancer (NSCLC). The goal is to see how safe and effective a pair of therapies—\[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G—are for people whose cancer has spread. The trial is currently looking for participants aged 18 and older who have been diagnosed with NSCLC that has progressed despite previous treatments. Participants should have measurable tumors and be healthy enough to complete the necessary tests.

If you join the trial, you will first have a PET scan using \[68Ga\]Ga DOTA-5G to identify your cancer. If the scan shows that the treatment may be suitable for you, you may receive the second therapy, \[177Lu\]Lu DOTA-ABM-5G. Throughout the study, your health will be closely monitored, and you'll be required to meet certain health criteria to ensure your safety. This trial offers a chance to access a potentially promising treatment while contributing to important research that could help others in the future.

Gender

ALL

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

Trial Officials

Julie L Sutcliffe, PhD

Principal Investigator

University of California, Davis

About University Of California, Davis

The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.

Locations

Sacramento, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0