Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET

Inclusion Criteria:

1. Age ≥ 18 (or age ≥ 20 as required by local regulation).

2. Histological or cytological confirmation of advanced/metastatic MET exon 14 skippingmutation (METΔex14) NSCLC, MET amplified NSCLC, or MET amplified gastric cancers asdetermined by FISH, qPCR or NGS by local liquid biopsy or tissue, solid tumors withMET fusions or oncogenic MET mutations or MET amplified other than GI/NSCLC.

3. ECOG performance status ≤ 1.

4. Existence of measurable or evaluable disease (according to Response evaluationcriteria in solid tumors [RECIST v1.1] criteria).

5. Subjects with asymptomatic primary CNS tumors or brain metastases are eligible forthe study if they meet protocol specified criteria.

6. Adequate organ function.

7. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Locally advanced solid tumor that is a candidate for curative treatment throughradical surgery and/or radiotherapy, or chemotherapy.

2. Presence or history of any other primary malignancy within the past 3 years otherthan a history of adequately treated basal or squamous cell carcinoma of the skin,or any adequately treated in situ carcinoma.

3. Major surgery within four weeks of the start of therapy.

4. Additional exclusion criteria for subjects with NSCLC with MET alterations: knownoncogene mutations (eg, ALK, ROS1, KRAS, EGFR, etc.) for which there are approvedtherapies.

5. Additional exclusion criteria for subjects with HCC with MET alterations: liverdysfunction greater than Child-Pugh Class A.

6. Clinically significant cardiovascular disease (either active or within six monthsbefore enrollment): myocardial infarction, unstable angina, coronary/peripheralartery bypass graft, symptomatic congestive heart failure (New York HeartAssociation Classification Class ≥ II), cerebrovascular accident or transientischemic attack, symptomatic bradycardia, requirement for anti-arrhythmicmedication. Ongoing cardiac dysrhythmias of CTCAE version 5.0 grade ≥ 2.

7. Any of the following cardiac criteria:

• Mean resting corrected QT interval (ECG interval measured from the onset of theQRS complex to the end of the T wave) for heart rate (QTc) > 470 msec obtainedfrom three ECGs, using the screening clinic ECG machine-derived QTc value

• Any clinically important abnormalities in rhythm, conduction, or morphology ofresting ECG (e.g., complete left bundle branch block, third degree heart block,second degree heart block, PR interval > 250 msec)

• Any factors that increase the risk of QTc prolongation or risk of arrhythmicevents such as heart failure, congenital long QT syndrome, family history oflong QT syndrome, or any concomitant medication known to prolong the QTinterval

8. Known clinically significant active infections not controlled with systemictreatment (bacterial, fungal, viral including HIV positivity).

9. Peripheral neuropathy ≥ Grade 2.