IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria:

• 1.Participants with the ability to understand and give written informed consent forparticipation in this trial, including all evaluations and procedures as specifiedby this protocol;

• 2.Male or female participants ≥ 18 years old;

• 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

• 4.Anticipated life expectancy of ≥ 12 weeks;

• 5.Participants, both male and female, who are either not of childbearing potentialor who agree to use at least one highly effective method of contraception during thestudy (begin from screening or within 2 weeks prior to the first dose, whichevercomes first, and continue until 6 months after the last dose of study drug).

• 6.Adequate bone marrow and organ function:

• 7.Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion fordose participants in dose escalation part);

• 8.Not a candidate for curable surgical resection or radical chemoradiation;

Exclusion Criteria:

• 1.Drugs and other treatments to be excluded;

• 2.Has adverse reactions resulting from previous anti-tumor therapies, which have notresolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia,fatigue, pigmentation and other conditions with no safety risk according toInvestigators' opinion) prior to first administration of the study drug;

• 3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immunecheckpoint inhibitor and documented adverse reaction which is severe and influencethe safety assessment of participants.

• 4.Allergic or hypersensitive to other monoclonal antibodies and/or CamptothecinDerivative based therapy, or any ingredients of IBI3014;

• 5.Known symptomatic central nervous system (CNS) metastases. The followingconditions could be considered enrollment: Participants with asymptomatic CNSmetastases (which means no neural system syndromes, no need of corticosteroidstreatment and diameter of metastases ≤ 1.5cm) or confirmed stable status accordingto Investigators' opinion after treatment, No midbrain, pons, cerebellum, meninges,medulla oblongata or spinal cord metastasis; and stable status for at least 4 weekswithout new or enlarged metastases definitively confirmed by clinical evidence, andwithdrawal of corticosteroids or anticonvulsant for at least 2 weeks prior to thefirst administration of study drug;

• 6.History of pneumonitis requiring corticosteroids therapy, or history of clinicallysignificant lung diseases (e.g. Interstitial lung disease, non-infectious pneumonia,or uncontrolled lung disease such as pulmonary fibrosis, severe radiationpneumonitis and acute lung injury) or who are suspected to have these diseases byimaging at screening period;

• 7.Participants with a clinically significant (CS) cardiovascular disease orcondition;

• 8.Participants with a significant gastrointestinal disease or condition,

• 9.Participants with biliary obstruction. Unless the blockage is treated locally,such as endoscopic stenting or percutaneous liver puncture and drainage, the totalbilirubin is reduced below 1.5 times ULN;

• 10.Ascites, pleural effusion, or pericardial effusion with symptoms and requiringintervention;

• 11.Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severecirrhosis;

• 12.Significant malnutrition, such as the need for intravenous fluids; Malnutritioncorrected for more than 4 weeks prior to the first administration of study drug isallowed;

• 13.Tumor invasion of surrounding important structures (such as mediastinal vessels,superior vena cava, trachea, esophagus, etc.) or at risk ofgastrointestinal/respiratory fistula;

• 14.Uncontrolled or clinically significant infections

• 15.History of immunodeficiency disease, including congenital or acquiredimmunodeficiency diseases;

• 16.Had a history of organ transplantation, allogeneic bone marrow transplantation orhematopoietic stem cell transplantation;

• 17.Other uncontrolled active disease or acute or chronic diseases or abnormallaboratory test that may: increase risk of study participation or study drugadministration, interfere with the interpretation of study results, and, disqualifythe participant for study participation in the Investigator's judgment;

• 18.History of other primary malignant tumors;

• 19.Women who are considered pregnant or are lactating;

• 20.Under neurological, psychiatric disorder or social condition that affectscompliance with study requirements, significantly increases the risk of adverseevents, or affects participants' ability to provide written informed consent;