A Study of DM001 in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Subjects must have the ability to understand and willingness to sign a writteninformed consent document.

2. Subjects who have pathologically or cytologically confirmed documentedmetastatic/advanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer,gastroesophageal cancer or CRC, and have progressed on standard therapy, orintolerant to standard therapy, or no standard therapy accessible to the subjectsdue to any reason.

3. Subjects must be ≥18 years of age at the time of signing the informed consent form.

4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance statusof 0 or 1.

5. Has a life expectancy of ≥3 months.

6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

1. Subjects have another active invasive malignancy within 5 years.

2. Current or history of a hematologic malignancy.

3. Primary central nervous system (CNS) malignancies or CNS metastases. Individualswith brain metastases can be enrolled only if treated, nonprogressive brainmetastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks.

4. Individuals with Gilbert's disease with ≥3 × ULN.

5. Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics,antivirals, or antifungals.

6. Has a medical history of clinically significant lung diseases or is suspected tohave these diseases by imaging at the screening period.

7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoingactive infection, active coagulopathy, uncontrolled cardiovascular disease,uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural andperitoneal effusion, psychiatric illness that would limit compliance with the studyrequirements and other serious medical illnesses requiring systemic therapies.

8. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF,QTcF=QT/[RR]1/3) >470 msec obtained from triplicate 12-lead ECGs at baseline; noconcomitant medications that would prolong the QT internal; no family history oflong QT syndrome.

9. Known human immunodeficiency virus infection, or active hepatitis B virus (HBV), orhepatitis C virus (HCV) infection. Chronic carriers of HBV infection (hepatitis Bsurface antigen-positive, undetectable, or low HBV DNA) who receive prophylactictreatment during the study can be enrolled. Subjects with a history of HCV infectionhave completed curative antiviral treatment and HCV viral load below the limit ofquantification and HCV antibody positive but HCV RNA negative due to prior treatmentor natural resolution should be eligible.

10. Females who are pregnant or lactating or who intend to become pregnant duringparticipation in the study are not eligible to participate.

11. Subjects who are of reproductive potential refuse to use effective methods of birthcontrol during the course of participation in the study and within 120 days for bothwomen and men of the last dose are ineligible to participate in the study.