Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas

Inclusion criteria

• \[68Ga\]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 GU, GI, GYN breast, cervical, uterine, or head and neck cancers 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)
• 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.
• 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 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:
• 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 bone, brain, lung or liver and identified on standard of care diagnostic imaging)

Exclusion criteria

• \[68Ga\]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)
• 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