A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors

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. The study will be conducted in 2 parts: the first part is the dose escalation part, and the second part is the Backfill part (as determined by the Sponsor). The dose escalation part will evaluate the safety and tolerability of KJ015 in participants with HER2-expressing locally advanced or metastatic solid tumors who have no standard therapy, are ineligible for surgical resection, or are not suitable for standard therapy or other approved therapies but have an inadequate clinical response. The Backfill part will further characterize the preliminary efficacy and safety of KJ015 in selected participants with solid tumors (including but not limited to G/GEJ, BC, CRC, BDC, HNSCC, NSCLC, etc.) at a minimum of two safe and tolerable dose levels, explore the relationship between the expression levels of HER2 protein and its mRNA and efficacy, as well as the HER 2 protein expression levels, transcription levels, and the correlation with efficacy in antitumor activity after KJ015 treatment.