A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

Inclusion criteria

• Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
• Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
• Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
• Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
• ECOG PS score: 0 or 1;
• Expected survival time ≥ 3 months;
• Adequate organ function at screening:

Exclusion criteria

• Previously treated with inhibitors against KRAS G12D mutation;
• The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
• Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
• Presence of other active malignant tumors in addition to primary tumors;
• Presence of serious lung diseases at screening;
• Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
• Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
• Complicated with clinically significant cardiovascular and cerebrovascular disorders;
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
• Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
• the investigator determines that participation in the study is not in the best interest of the subject.