This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors.
Aged ≥ 18 years (at time of free and informed consent).
Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.
Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital
Concurrent participation in another clinical study.
Received radiotherapy within 2 weeks prior to the first dose.
Underwent major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose or plan to undergo major surgery during the study. Underwent interventional or ablation surgery aimed at treating the tumor within 2 weeks before the first dose.
Prior allogeneic bone marrow transplant or prior solid organ transplant.
Shanghai Bao Pharmaceuticals Co., Ltd.
Lead sponsor