A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors

Inclusion Criteria:

• The subject voluntarily participates in this study, signs the informed consent form,and has good compliance;

• Gender is not restricted; age (calculated as of the date of signing the informedconsent form): 18-75 years old;

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; expectedsurvival period ≥ 3 months;

• Patients with histologically or cytologically confirmed advanced malignant solidtumors, including but not limited to epithelial ovarian cancer, fallopian tubecancer, primary peritoneal cancer, breast cancer, prostate cancer, etc.;

• Advanced solid tumors that have failed standard treatment (disease progression orintolerance) or for which there is no standard treatment plan;

• For Phase Ib (dose expansion stage), except for patients receiving maintenancetreatment for ovarian cancer/fallopian tube cancer/primary peritoneal cancer, otherpatients are required to have target lesions meeting the RECIST 1.1 criteria. ForPhase Ia (dose escalation stage), measurable lesions are not required;

• Good function of major organs;

• Women of childbearing age must agree to use effective contraceptive measures duringthe study and within 6 months after the end of the study; serum or urine pregnancytest must be negative within 7 days before enrollment, and they must benon-lactating subjects; men must agree to use effective contraceptive measuresduring the study and within 6 months after the end of the study.

Exclusion Criteria:

• History of other malignant tumors within 3 years prior to the first administrationof the study drug;

• Failure to recover from toxicity and/or complications of previous interventions toCTCAE ≤ Grade 1;

• Risk of bleeding;

• Arterial thrombotic events occurring within 6 months prior to the firstadministration;

• Suffering from ≥ Grade 2 myocardial ischemia or myocardial infarction,supraventricular or ventricular arrhythmias, and ≥ Grade 2 congestive heart failure;poorly controlled blood pressure;

• History of psychotropic substance abuse with inability to abstain, or presence ofmental disorders; patients with epilepsy requiring treatment; or patients withsevere mental or neurological diseases;

• Active or uncontrolled severe infections;

• Active syphilis; HIV infection or other immunodeficiency diseases; active hepatitisB or active hepatitis C;

• Complicated with moderate to severe pulmonary diseases that significantly affectrespiratory function;

• Patients with active autoimmune diseases requiring systemic treatment (e.g.,disease-modifying drugs, corticosteroids, or immunosuppressants);

• Receipt of systemic treatment with prednisone > 10 mg/day or equivalent drugs, orany other form of immunosuppressive therapy within 2 weeks prior to administration;

• History of organ transplantation (except corneal transplantation), allogeneic orautologous hematopoietic stem cell transplantation;

• Poorly controlled diabetes mellitus;

• Patients with leptomeningeal (including arachnoid and pia mater) metastases;

• Known central nervous system (CNS) involvement;

• Presence of massive serous cavity (pleural, peritoneal, or pericardial) effusionsrequiring repeated drainage to relieve clinical symptoms, or receipt of therapeuticserous cavity effusion drainage within 2 weeks prior to treatment;

• Current intestinal obstruction;

• Known allergy to the components of the study drug;

• Receipt of anti-tumor treatments such as radiotherapy, chemotherapy, targetedtherapy, or immunotherapy within 4 weeks prior to the first administration;

• Receipt of Chinese patent medicines explicitly indicated for anti-tumor use in theirdrug labels approved by National Medical Products Administration (NMPA) within 2weeks prior to the first administration;

• According to the investigator's judgment, subjects with concomitant diseases thatseverely endanger their safety or affect the completion of the study, or thosedeemed unsuitable for enrollment for other reasons.