Clinical Trials

Inclusion Criteria:

* Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
* Able and willing to comply with protocol visits and procedures
* Aged ≥ 18 years
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Tumor types as below:

For Part 1 and Part 2: Pathologically confirmed diagnosis of an advanced solid tumor.

For Part 3 (Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease)

* Adequate organ and bone marrow function.
* Have at least 1 extracranial measurable tumor lesion.
* Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.

Exclusion Criteria:

* Prior treatment with an agent targeting CDH17
* Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
* Have received a topoisomerase I inhibitor within protocol defined time before the first dose of study drug.
* Have received an ADC consisting of a topoisomerase I inhibitor.
* Concurrent enrollment in another clinical study, unless it is an observational clinical study.
* Inadequate washout period for prior anticancer treatment before the first dose of study drug
* Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study.
* Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
* Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
* Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.
* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
* A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis.
* Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
* Uncontrolled third-space fluid that requires repeated drainage.
* Digestive system disease that may cause bleeding, perforation, jaundice, gastrointestinal obstruction.
* An active tuberculosis based on medical history.
* Known human immunodeficiency virus (HIV) infection.
* Active hepatitis C infection.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/29/2025. Questions regarding updates should be directed to the study team contact.