68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)

Inclusion Criteria:

• [68Ga]Ga-DOTA-FAPI PET/CT Inclusion Criteria: (i) adult participants (aged 18 years ororder); (ii) Confirmed presence of various types of locally advanced or metastaticcancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cmor lymph node > 1.5 cm in short axis); (iii) Participant must have documented tumorprogression during or following at least one prior systemic regimen as established byCT or MRI scan within 28 days of enrollment; (iv) participants who were able toprovide informed consent (signed by participant, parent or legal representative) andassent according to the guidelines of the Clinical Research Ethics Committee. (v)Eastern Cooperative Oncology Group Performance Status ≤ 2; (vi) Participant must havecompleted prior therapy at least 1 month (washout period) prior to [68Ga]Ga DOTA-FAPIPET scan. Any clinically significant toxicity (with the exceptions of hair loss andsensory neuropathy) related to prior therapy resolved to Grade 1 or baseline;
• Hematologic parameters defined as: (i)Absolute neutrophil count (ANC) ≥ 1000 cells/mm3; (ii)Platelet count ≥ 100,000/mm3; (iii)Hemoglobin ≥ 8 g/dL;
• Blood chemistry levels defined as: (i) AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN); (ii) Totalbilirubin ≤ 2 times ULN; (iii) Creatinine ≤ 2 times ULN; (iv) Anticipated lifeexpectancy ≥ 6 months; (v) Able to remain motionless for up to 10-20 minutes per scan;
• [177Lu]Lu-DOTA-FAPI therapy Inclusion Criteria: (i) Completion of entry into [68Ga]Ga-DOTA-FAPI PET study and completion of scan; (ii) CThe presence of at leastone measurable disease by [68Ga]Ga-DOTA-FAPI PET/CT (SUVmax > 10-fold above normallung or liver);

• Exclusion Criteria: (i) 1.Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA); (ii)Participants with Class 3 or 4 NYHA Congestive Heart Failure (iii) Clinically significant bleeding within two weeks prior to trial entry (e.g.gastrointestinal bleeding, intracranial bleeding); (iv) Pregnant or lactating women; (v)Major surgery, defined as any surgical procedure that involves general anesthesiaand a significant incision (i.e. larger than what is required for placement of acentral venous access, percutaneous feeding tube, or biopsy) within 28 days prior tostudy day 1 or anticipated surgery within the subsequent 6 weeks; (vi)Has anadditional active malignancy requiring therapy within the past 2 years; (vii)Active,uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy; (viii)Psychiatric illness/social situations that would interfere with compliance withstudy requirements; (ix)Cannot undergo PET/CT scanning because of weight limits (350lbs); (x)INR>1.2; PTT>5 seconds above UNL