A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

Korábbi kezelés

• Previous or active history of clinically significant cardiovascular dysfunction.
• Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.
• Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.
• Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.

Más betegség

• Presence of known coexisting other cancer driver genes.
• Presence of active infection.
• History of central nervous system (CNS) diseases.
• Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.

Egyéb

• Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.
• Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.

• Voluntarily participate in the study and sign the informed consent form.
• Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.
• Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.
• Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.
• At least one measurable lesions according to RECIST v1.1
• Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.
• Have sufficient organ function.