A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors (NCT07036185) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors
China66 participantsStarted 2025-06-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Aged ā„ 18 years (at time of free and informed consent).
ā. Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.
ā. Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.
ā. Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital
ā. Organ function must meet the following criteria:
ā. Expected survival ā„ 3 months.
ā. Participants must be capable of and willing to comply with the visit and procedure requirements outlined in the protocol.
Exclusion criteria
ā. Concurrent participation in another clinical study.
ā. Received radiotherapy within 2 weeks prior to the first dose.
ā. 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.
ā. Prior allogeneic bone marrow transplant or prior solid organ transplant.
What they're measuring
1
Dose Escalation Part: Adverse Event collection and assessment
Timeframe: at least 21 days or up to 24 weeks
2
Dose Escalation Part: Backfill part recommended extension dose (RED)
. Received systemic corticosteroids or other immunosuppressive treatments within 2 weeks prior to the first dose.
ā. Received an anthracycline cumulative dose of doxorubicin exceeding 500 mg/m2 or an equivalent dose of other anthracyclines prior to the first dose.
ā. History of leptomeningeal carcinomatosis or carcinomatous meningitis.