Tumorad: This study is recruiting adults with advanced solid cancers who have no standard of care treatment options to determine the maximum tolerated dose, safety and tolerability of targeted radionuclide therapyA Phase I/IIa, Dose Escalation and Dose Expansion, First-in-human, Open-label, Multicenter, Single-arm Study Evaluating the Safety, Tolerability, Dosimetry, and Early Efficacy of [177Lu]Lu-SN201 in Participants With Progressive or Treatment-refractory Locally Advanced Unresectable, Metastatic or Recurrent Solid Tumors

Inclusion

1. Male or female participants ≥ 18 years of age on the day of signing informed consent.
2. Histologically or cytologically documented, recurrent, locally advanced, or metastatic solid malignancy that has failed at least one prior systemic standard therapy, or for which standard therapy is not appropriate, or for which no standard therapy exists.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
4. Life expectancy ≥ 3 months.

5. Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements, to be conducted within 28 days before the start of the study IMP administration:

   1. Hemoglobin ≥ 9.0 g/dL (transfusions are allowed).
   2. Absolute neutrophil count (ANC) ≥ 1500/mm3.
   3. Platelet count ≥ 100,000 mm3.
   4. Total bilirubin ≤ 2.5 x upper limit of normal (ULN) (in participants with liver metastases ≤ 5 ULN).
   5. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 x ULN.
6. On a stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and prothrombin/international normalized ratio and partial thromboplastin time (PT/INR and PTT, respectively) test results are compatible with the acceptable benefit-risk ratio at the Investigator's discretion.
7. Serum creatinine ≤ 1.5 x ULN and estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (per local values).

8. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

   1. Male participants must agree to use a highly effective method of birth control as defined in ICH M3(R2) starting with the first dose of study medication through 120 days after the last dose of study medication.

   2. Female participants of childbearing potential* must have a negative pregnancy test documented at Screening and Baseline and be willing to use a highly effective method of contraception** or practice abstinence starting from ICF signature through to 120 days after the last dose of study medication.

      • A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., had had menses at any time in the preceding 24 consecutive months).

        • Effective contraception is defined as contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system).
9. Written informed consent to study participation.
10. Be able to understand and comply with the requirements of the study, as judged by the Investigator.
11. Phase I: At least one lesion as per RECIST v1.1.
12. Phase IIa: At least one measurable lesion as per RECIST v1.1.