A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer

Inclusion Criteria:

1. Male or female patients ≥ 18 years of age.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

3. Subjects with locally advanced or metastatic solid tumors confirmed by histology orcytology who have not benefitted from or are intolerant of available therapy(ies)associated with a reasonable likelihood to confer clinical benefit because of knownCDH3 expression, including, albeit not limited to: HNSCC, ESCC, BC, NSCLC, EC, UC,CRC, OC, pancreatic cancer, and prostate cancer.

4. Agree to provide previously archived tumor tissue samples, or newly obtained corebiopsy, or excisional biopsy of a previously unirradiated tumor lesion (formalinfixed, paraffin embedded tissue blocks)

5. Subjects with at least one measurable lesion according to RECIST 1.1. Lesionssituated in a previously irradiated area are considered measurable if progressionhas been demonstrated in such lesions

6. Life expectancy ≥ 3 months

7. Subjects with adequate organ function

8. Men or women of childbearing potential must use a highly effective method ofcontraception during the study and continue to take contraception measures for 6months after the last dose of the study drug.

9. Patients voluntarily participate in the study and should provide a written informedconsent.

Exclusion Criteria:

1. Pregnant or lactating women

2. Prior systemic anticancer treatment, including investigational agents, within 5half-lives or 4 weeks before the first dose (whichever is shorter)

3. Subjects diagnosed with immunodeficiency within 7 days prior to the first dose ofthe study drug; or subjects who are receiving longterm systemic steroid therapy orany other form of immunosuppressive therapy

4. Previously received allogeneic tissue/solid organ transplantation

5. Patients who have received radiation therapy within 2 weeks prior to the start ofstudy treatment or with a history of radiation pneumonitis.

6. Known active CNS metastases and/or cancerous meningitis. Subjects with previouslytreated brain metastases who meet the following conditions are permitted toparticipate in the study: radiologically stable, that is, repeat imaging shows noevidence of progression for at least 4 weeks, clinically stable, and no steroidtherapy is required for at least 14 days prior to the first dose of study treatment

7. Active viral infection requiring systemic therapy during the screening period

8. Clinically uncontrolled pericardial effusion, pleural effusion, or ascites atscreening

9. Has a history of (non-infectious) pneumonitis / interstitial lung disease thatrequired steroids or has current pneumonitis / interstitial lung disease

10. Hypertension that cannot be well-controlled with medical treatment. Notwell-controlled is defined as systolic blood pressure >150 mmHg or diastolic bloodpressure >90 mmHg (adjustment of hypertensive medication prior to study initiationis permitted, but the mean of the most recent three consecutive blood pressurerecords prior to study entry must be ≤150/90 mmHg [with at least 2- minute intervalbetween each measurement])

11. Cardiovascular disease of clinical significance: Including New York HeartAssociation [NYHA] Class II-IV, congestive heart failure, second-degree or higherheart block, myocardial infarction within the past 3 months, unstable arrhythmia orunstable angina, marked QT interval prolongation (12-lead ECG showingbaseline-corrected QTc interval >480 ms), cerebral infarction within 3 months, orhaving received PTCA or CABG within 6 months

12. Subjects with active or chronic corneal disorders, with other active ocularconditions requiring ongoing therapy or with any clinically significant cornealdisease that prevents adequate monitoring of drug-induced keratopathy

13. Grade 2 or higher peripheral neuropathy. Other toxicities caused by prior anti-tumortherapy has not recovered to ≤ grade 1 (per CTCAE 5.0) (except for alopecia,pigmentation, and other events judged by the Investigator to be tolerable) or thelevel specified by the inclusion/exclusion criteria in this study

14. Subjects with any active infection that requires anti-infective therapy judged bythe investigators

15. Known hypersensitivity or delayed hypersensitivity reactions to the same classand/or any components of BC3195

16. Subjects who received strong CYP3A4 inhibitors and Strong CYP3A4 inducers within 14days or 5 half-lives whichever is shorter, before the first dose (refer to Appendix 7 for a list of strong CYP3A4 inhibitors and inducers)

17. Subjects are not suitable for participating the study judged by the investigators

18. Subjects with poor compliance, who are unwilling to or unable to follow studyprocedures