A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors

Inclusion Criteria:

* Able to understand and comply with study procedures
* At least 18 years old
* Phase 1 Part dose-escalation and Phase 1 Part expansion Cohort 1 only: Presence of an advanced-stage/metastatic, solid tumor in non-curable state as per current medical knowledge, for which there is either no further approved therapeutic alternative available or the subject is not eligible for them or, for which the subject has completed a minimum of two lines of approved systemic therapy in the advanced-stage/metastatic setting.
* Phase 1 Part expansion Cohort 2 only: Presence of an advanced-stage/metastatic disease of the following indications: melanoma (skin or uveal), NSCLC, urothelial, breast cancer in non-curable state as per current medical knowledge, for which there is either no further approved therapeutic alternative available or the subject is not eligible for them or, for which the subject has completed a minimum of two lines of approved systemic therapy in the advanced-stage/metastatic setting.
* HLA-A\*02:01 genotype.
* MAGE-A1+ tumor positive for MAGE-A1
* At least one measurable lesion, that can be accurately measured as per RECIST Version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Life expectancy \> 3 months as assessed by the Investigator
* All toxicities related to prior therapy must have recovered to baseline or Grade ≤ 1 based on CTCAE v5.0
* Immune-related adverse events (irAEs) from previous therapies must have recovered to baseline or Grade ≤ 1

Exclusion Criteria:

* Any tumor-directed therapy within 14 days before start of conditioning therapy
* Any other MAGE-A1-targeting therapy.
* Pre-existing arrhythmia, uncontrolled angina pectoris, presently uncontrolled heart failure, or any myocardial infarction/coronary event as well as any thromboembolic event at any time \< 6 months prior to screening.
* Left ventricular ejection fraction (LVEF) \< 45% as measured by an echocardiogram
* History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (within 6 months prior to screening)
* Active allergy requiring continuous systemic medication or active infections requiring IV/PO anti-infectious therapy
* History of or clinical evidence of CNS primary tumors or metastases, unless they have been previously treated, and have been stable for at least 4 weeks prior to trial entry
* Major surgery within last 4 weeks prior to consent
* Active disease/ongoing infection with HIV, HBV, HCV, TB, syphilis, or SARS-CoV-2
* Receipt of any organ transplantation, except for transplants that do not require immunosuppression
* Any vaccine administration within 4 weeks of IP administration.