Status:
UNKNOWN
Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Neoplasms
Neoplasms Malignant
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Immuno-Oncology (IO) therapies have revolutionized cancer therapy and are becoming the standard of care for many cancers. Monitoring how well IO therapies work against cancer is difficult due to the c...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Cohort 1):
- At least one imageable tumor greater than or equal to 15 mm in the longest diameter
- Confirmed diagnosis of cancer with a high likelihood of response to immuno-oncology therapy (melanoma or non-small cell lung cancer, or other malignancies with sponsor approval) and planned mono- or combination therapy with immuno-oncology therapy
- Life expectancy of greater than 6 months
- Inclusion Criteria (Cohort 2):
- At least one imageable tumor greater than or equal to 15 mm in the longest diameter or a tumor assessable by PET in the opinion of the radiologist
- Received treatment with an immune checkpoint inhibitor with evidence of response
- Life expectancy of greater than 6 months
- Exclusion Criteria:
- Subjects who plan to receive chemotherapy or radiation therapy during study participation
- Prior history of failed immune checkpoint inhibitor therapy
- Subjects who require steroid or other immunosuppressive medications within 2 weeks of the PET scan.
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using effective methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening and agree to avoid becoming pregnant for 24 hours following study drug administration.
- Females and males must agree to refrain from sexual activity or to use effective contraceptive methods for 24 hours following study drug administration and during study participation
Exclusion
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04721756
Start Date
April 12 2022
End Date
April 1 2024
Last Update
April 25 2022
Active Locations (1)
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1
Olivia Newton-John Cancer Institute and Austin Health
Heidelberg, Victoria, Australia