A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1)

Inclusion Criteria:

For Phase 1 and Phase 2:

1. Patients have voluntarily signed the informed consent.

2. Patients are willing and able to comply with the protocol-related procedures (including screening evaluations), such as visits, treatment plans, laboratoryassessments, and other requirements of the study.

3. Male or female aged ≥18 years old.

4. Patients meet the following diagnoses:

• Patients have histologically or cytologically documented diagnosis of locallyadvanced or metastatic solid tumors with evidence of progressive diseaseaccording to RECIST 1.1, and

• Patients are intolerant to or have progressed on all established standardtherapies associated with clinical benefit or patients consent that they may bedelaying or forgoing treatments known to confer a clinical benefit for theirdisease, or

• No additional established line of standard therapy is available, or

• There is a contraindication for the indicated standard therapies in the opinionof the Investigator.

(Note: Tumor types of primary interest in Phase 1 include but are not limited tomalignant melanoma, renal cell carcinoma, non-small cell lung cancer, gastriccarcinoma, hepatocellular carcinoma, pancreatic adenocarcinoma, breast carcinoma,ovarian carcinoma, and colorectal carcinoma.)

5. Patients have at least one measurable tumor lesion, defined as a lesion with thelongest measurable diameter of non-lymph node lesions by imaging (CT/MRI) of ≥10 mmor the short diameter of a single pathological lymph node lesion of ≥15 mm.

6. Expected life expectancy of >12 weeks per the Investigator.

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Phase 1.ECOG score of 0 to 2 for Phase 2.

8. If a patient has had prior major surgery, at least 4 weeks must have elapsed at thetime of screening.

9. Patients have adequate pulmonary, cardiovascular, hematological, liver, and renalfunction, per Investigator assessment.

10. Patients have not received any IL-2 therapy within 12 months before the first doseof LAT010.

11. Laboratory values at screening are as follows: a. Hematology: i. Absolute neutrophil count (ANC) ≥1,500 cells/mm3 ii. Plateletcount ≥75,000 cells/mm3 (no blood components or cell growth factors are used assupportive care within 7 days before the first dose of LAT010) iii. Hemoglobin ≥9.0g/dL, transfusion of red blood cells allowed to reach threshold target if >7 days b.Renal: i. Creatinine clearance >30 mL/min as derived from the Cockcroft-Gaultglomerular filtration rate estimation c. Coagulation: i. International NormalizedRatio (INR) ≤1.5× the upper limit of normal (ULN) ii. Prothrombin time (PT) oractivated partial thromboplastin time (APTT) ≤1.5×ULN unless undergoinganticoagulation therapy d. Liver: i. Aspartate transaminase (AST) and alaninetransaminase (ALT) ≤3.0×ULN without liver metastasis or ≤5×ULN with liver metastasisii. Bilirubin <1.5×ULN (unless Gilbert syndrome is confirmed)

12. Any toxicity of previous treatment has recovered to Grade ≤1, unless the toxicity isjudged by the Investigator to pose no safety risk, such as alopecia (any grade) orfatigue (up to Grade 2 allowed).

13. Female patients of childbearing potential and sexually active male patients withfemale partners of childbearing potential must agree to use effective contraceptivemeasures (including concomitant use of a spermicide with barrier method,intrauterine device, or hormonal contraceptives) from signing the informed consentform to at least 90 days after the last dose of LAT010. Female patients ofchildbearing age and women <12 months after menopause must have a negative pregnancytest result within 7 days before the first dose of LAT010.

14. Male patients must not donate sperm starting at screening and throughout the studyperiod and for at least 90 days after the final study drug administration. For Phase 2 only:

15. Patients must meet the following criteria:

16. Patients are willing and able to undergo baseline and on-treatment biopsies ofthe tumor. If a patient has residual tumor masses that can only be accessedwith significant risk, available archived biopsies (frozen or formalin-fixed)may serve as baseline specimens with the Sponsor's approval.

17. Patients have been diagnosed and histologically confirmed with a tumor typebeing selected for the Phase 2 trial.

18. Patients have received the established standard therapies for the selectedtumor type prior to enrolling to this study and patients consent that they maybe delaying or forgoing specific treatments known to confer a clinical benefitfor their disease.

19. Must have received no more than 1 prior line of anti-angiogenic therapy, e.g.,anti-vascular endothelial growth factor (anti-VEGF) therapy

Exclusion Criteria:

1. Cardiovascular exclusions:

2. Patient has a medical history of an arterial thrombotic event, stroke, ortransient ischemia attack within the past 6 months.

3. Patient has a medical history of symptomatic congestive heart failure (New YorkHeart Association classes III or IV) or an uncontrolled clinically significantcardiac arrhythmia that requires treatment.

4. Patient has a medical history of myocardial infarction or unstable anginawithin 6 months before the first dose of LAT010.

5. Patient has a QTc prolongation to >480 milliseconds (ms) based on a 12-leadECGs in triplicate.

6. Other exclusions:

7. Patient is actively enrolled in another clinical study, unless it is anobservational (noninterventional) clinical study or the follow-up component ofan interventional study.

8. Use of another systemic anti-cancer therapy within 3 weeks or 5 half- livesafter the first dose of LAT010, whichever is shorter.

9. Patient has active central nervous system (CNS) metastases. However, definitelytreated CNS metastases (such as surgery, radiotherapy) that are stable for atleast 2 weeks prior to the first dose of LAT010 are acceptable.

10. Patient has another active primary malignancy that has not been treated withcurative intent. Exceptions could be made upon discussion with the MedicalMonitor. However, non-metastatic cutaneous basal cell or squamous cellcarcinoma, or non-muscle invasive bladder cancer are acceptable.

11. Patient has history of severe irAEs from a previous treatment, which aredefined as a Grade 4 event requiring corticosteroid treatment or a Grade 3event requiring corticosteroid treatment of >10 mg/day prednisone or equivalentdose for >12 weeks.

12. Recent medical concerns exclusions:

13. Patient has evidence of active infection requiring IV antibiotics within 7 daysprior to the first dose of LAT010.

14. Patient has active uncontrolled bleeding within 7 days prior to the first doseof LAT010.

15. Patient has serious or non-healing wound, fistula, skin ulcer, or non-healingbone fracture within 7 days prior to the first dose of LAT010.

16. Patient has had a live virus vaccine within 30 days prior to the first dose ofLAT010 (Note: Inactivated seasonal flu vaccine is acceptable. COVID-19vaccination is also allowed.)

17. Patient has known replicating human immunodeficiency virus infection, activehepatitis B infection, or hepatitis C infection. However, hepatitis B virus (HBV)carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL) orpatients with cured hepatitis C (negative HCV RNA test) may be enrolled. Patientswith treated non-replicative disease are acceptable.

18. Patient is taking corticosteroids >10 mg/day of prednisone or equivalent.

19. Patient has had an organ transplantation or is on systemic immunosuppressivetherapy.

20. Patient has a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms ofCoronavirus disease 2019 (COVID-19) on Day -2 or Day -1.

21. Patient has a serious illness considered by the Investigator to be unsuitable forparticipating in this study.

22. Any condition that, in the opinion of the Investigator, may interfere with theevaluation of the study drug or interpretation of the patient's safety or studyresults.

23. Patient has a history of sensitivity to LAT010, or components thereof, or a historyof drug or other allergy that in the opinion of the Investigator or Medical Monitor (if appropriate), contraindicates their participation.

24. Patient has any illness, medical condition, organ system dysfunction, or socialsituation, including mental illness or substance abuse, that is deemed by theInvestigator to be likely to interfere with a patient's ability to sign the informedconsent form (ICF), adversely affect the patient's ability to cooperate andparticipate in the study, or compromise the interpretation of study results.

25. Patient is breastfeeding or pregnant as confirmed by pregnancy tests performedwithin 7 days before the first dose of LAT010.

26. Patient is unwilling or unable to follow protocol requirements.