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.
Single group
KJ015 Injection (Subcutaneous Injection)
DrugKJ015 is administered via subcutaneous injection, with the dosing frequency set at either Q3W.
Dose Escalation Part: Adverse Event collection and assessment
Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).
Dose Escalation Part: Backfill part recommended extension dose (RED)
Backfill recommended extension dose
Backfill Part: Adverse Event
Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability.
Immunogenicity
Immunogenicity of KJ1015 (Anti-KJ015 antibody) in patients
Objective Response Rate (ORR)
ORR was defined as the patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment as defined in RECIST 1.1.
Disease Control Rate (DCR)
DCR was defined as the patients with a best overall response of either CR, PR or stable disease (SD) .
Progression-Free Survival（PFS）
PFS was defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression) regardless whether the patient withdrew from the assigned study treatment or received another anticancer prior to progression.
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