The Safety and Dosimetry Study of 177Lu-LNC1004 Injection

Inclusion Criteria:

• Patients must have the ability to understand and sign an approved informed consentform (ICF).

• Patients must have the ability to understand and comply with all protocolrequirements.

• Aged 21 years or older

• Patients must have histological, pathological, and/or cytological confirmation ofadvanced/metastatic solid tumor that is refractory to or has progressed followingprior treatment and based on the current guidelines, there is no recommendedtreatment

• Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1

• Overexpression of fibroblast activation protein of the target lesions at 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) withpositive uptake (higher than adjacent background).

• Eastern Cooperative Oncology Group (ECOG) performance status (ECOG PS) score of 0 or 1

• Adequate organ function as defined by:

1. Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)

2. Hemoglobin (Hb) > 9.0g/dL

3. Absolute neutrophil count (ANC) > 1.5 x 10^9/L

4. Platelets ≥100 x 109/L

5. International normalized ratio (INR) < 1.5 for patients that are not onwarfarin

6. Prothrombin time (PTT) < 2 x ULN

7. Total bilirubin < 1.5 x ULN

8. Serum albumin > 2.8 g/dL

9. Alanine aminotransferase (ALT) <3 x ULN, or <5 x ULN if deemed related to livermetastases from solid tumor

10. Aspartate aminotransferase (AST) <3 x ULN, or <5 x ULN if deemed related toliver metastases from solid tumor

• All other toxicity parameters must be NCI-CTCAE v.5.0 Grade 0 or 1

• Women of childbearing potential (WOCBP) must have a negative pregnancy test at studyentry. Subjects not considered WOCBP are those without menses for ≥ 12 consecutivemonths, and those who have undergone hysterectomy and/or bilateralsalpingo-oophorectomy. WOCBP must be willing to use acceptable methods of birthcontrol (i.e., a hormonal contraceptive, intra-uterine device, diaphragm withspermicide, or condom with spermicide, or abstinence) for the duration of the studyand 6 months after the last dose of treatment.

• Male participants with partners of childbearing potential are required to usebarrier contraception in addition to having their partner use another method ofcontraception during the study and for 6 months after the last dose of treatment.Male participants will also be advised to abstain from sexual intercourse withpregnant or lactating women, or to use condoms.

• Previous surgery no less than 4 weeks prior to study entry.

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to 177Lu-LNC1004 as assessed from medical records

• Participant has had prior chemotherapy or radical radiotherapy within 4 weeks beforethe first administration of study drug

• Participant has had prior targeted cancer therapy, immunotherapy, or treatment withan investigational anticancer agent ≤ 14 days prior to receiving study treatment (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies) beforethe first administration of study drug.

• Received prior radiopharmaceutical therapy or radioembolization, or prior extensiveexternal beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney,or received any EBRT within 2 weeks prior to administration of study treatment

• Participant has not fully recovered from major surgery or significant traumaticinjury prior the first dose of study drug or expects to have major surgery duringthe study period or within 3 months after the last dose of study drug.

• Life expectancy < 6 months as assessed by the treating physician

• > 80% liver involvement by tumor

• > 25% bone marrow involvement by tumor

• Clinically significant abnormalities on electrocardiogram (ECG) at screeningincluding QTcF > 470 ms regardless of sex or subjects who cannot tolerate highvolume load.

• Toxicities from prior therapies that have not resolved to grade 1 or grade 0

• Active and clinically significant bacterial, fungal, or viral infection, includinghepatitis B (HBV), hepatitis C (HBC), know human immunodeficiency virus (HIV), oracquired immunodeficiency syndrome (AIDS)-related illness

• Known brain metastases and/or carcinomatous meningitis, unless these metastases havebeen treated and stabilized

• Uncontrolled diabetes mellitus as defined by a HbA1c >9%

• Uncontrolled, intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements

• Prior external beam radiation therapy involving >25% of the bone marrow

• Unmanageable urinary incontinence rendering the administration of 177Lu-LNC1004unsafe

• Other known co-existing malignancies except non-melanoma skin cancer and carcinomain situ of the uterine cervix, unless definitively treated and with no evidence ofrecurrence

• Unable to comply with relevant contact precautions post 177Lu-LNC1004 treatment

• Any other condition that may increase the risk associated with study participationor interfere with its interpretation.