This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.
1. Voluntarily participate in the study after being fully informed, sign the written ICF, and agree to comply with the procedures specified in the protocol.
2. Male or female aged ≥18 years at the time of signing the ICF.
3. Subjects with pathologically confirmed locally advanced or metastatic solid tumors.
4. Subjects confirmed to be KRASG12D mutation-positive in tumor tissue samples. Subjects may use historical results from local laboratories (within 2 years before signing the ICF).
1. Previous treatment with KRASG12D inhibitors. Note: Except for subjects in Phase Ib, who may have received previous treatment with KRASG12D inhibitors.
2. Previous treatment with focal adhesion kinase (FAK) inhibitors.
3. Received any anti-cancer drug treatment (including cytotoxic therapy, targeted therapy, biological therapy, or hormonal therapy other than alternative therapy) or other investigational drug treatment and radiotherapy within 14 days before the first dose.
4. Have other KRAS mutations (excluding KRASG12D mutation), and have other positive mutation sites with available marketed targeted drugs.
InxMed (Shanghai) Co., Ltd.
Lead sponsor
Ranok Therapuetics Co. Ltd.
Collaborator
InxMed (Shenzhen) Co.,Ltd.
Collaborator