Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors

Inclusion Criteria:

• Written informed consent;

• ≥18 years old and ≤80 years old, gender: male or female;

• Histologically or cytologically confirmed unresectable advanced/metastatic solidtumor that has relapsed or progressed on or after standard systemic treatments, orrefused the standard treatment, or for which no standard treatment is available;

• Presence of at least one measurable lesion according to Response Evaluation Criteriain Solid Tumours (RECIST) Version 1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;

• Life expectancy ≥3 months;

• Participant must have adequate main organ function;

• Fertile female patients must have a negative serological pregnancy test within 7days before the first dosing and be willing to use effective birthcontrol/contraception to prevent pregnancy during the study period up to 6 monthsafter the last dosing of the study. Male patients must agree to have no spermdonation plans and to use effective contraceptive methods during the study perioduntil 6 months after the last dose of the study. Postmenopausal women must haveamenorrhea for at least 12 months before they are considered infertile.

Exclusion Criteria:

• Within the defined washout periods for prior anti-cancer treatments;

• Participant is currently participating or has participated in a study of aninvestigational agent or using an investigational device within 4 weeks of firstdose of HY07121.

• Any other malignancy within 2 years prior to the first dose of the study treatmentexcept for localized cancers that are considered to have been cured and in theopinion of the Investigator present a low risk for recurrence.

• Participant has not recovered (i.e., to Grade 1 or to baseline) from previousanticancer therapy-induced Adverse Events (AEs).

• Participants with a history of recently (within previous 2 years of the first doseof the study treatment) active diverticulitis or symptomatic peptic ulcer disease;

• Major surgery within 4 weeks of receiving the first dose of study treatment;

• Participant has Symptomatic Central Nervous System (CNS) metastases, or CNSmetastases requiring CNS-directed local therapy (such as radiotherapy or surgery) orcorticosteroids therapy within 4 weeks of first dose of study treatment;

• Participants with untreated or under treatment for tuberculosis, including but notlimited to tuberculosis; Patients who have received standardized anti-tuberculosistreatment and have been confirmed cured by the researchers can be included;

• Participants with clinically significant cardiovascular diseases, in the past 6months prior to the first dose of the study treatment; symptomatic coronary heartdisease requiring drug treatment; arrhythmia requiring drug treatment; oruncontrolled hypertension;

• Known Human Immunodeficiency Virus (HIV) infection or known AcquiredImmunodeficiency Syndrome (AIDS);

• Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibodypositive, and confirmed positive test;

• Active known or suspected autoimmune disease.

• History of non-infectious pneumonitis that has required a course of oral orintravenous steroids to assist with recovery, or interstitial lung disease or severeobstructive pulmonary disease;

• History of severe allergy;

• History of allogeneic organ transplantation or graft-versus-host disease;

• Have received live/attenuated vaccines and mRNA vaccines within 4 weeks prior toscreening or plan to receive live/attenuated vaccines and mRNA vaccines during thestudy period;

• Any active infection requires systemic treatment via intravenous infusion within 4weeks prior to the first dose of study treatment;

• Known psychiatric disorder or drug abuse that would interfere the trialrequirements;

• Participant with uncontrolled pleural effusion, pericardial effusion or peritonealeffusion or need drainage;

• In addition to the tumors present at the time of entry into the study, other activemalignancies were present within 3 years prior to the first dose (not excludinglocally cured tumors, such as skin basal cell carcinoma, superficial bladder canceror carcinoma in situ of the breast, etc.);

• Participants considered unsuitable for participation in this study by theinvestigators.