A Study of KM602 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorXuanzhu Biopharmaceutical Co., Ltd.

About this trial

This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.

Eligibility criteria

Qualifiers

Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)

All patients must have at least one measurable lesion at baseline according to RECIST v1.1

ECOG performance status of 0 or 1

Life expectancy of ≥ 12 weeks

Disqualifiers

Patients with meningeal metastasis or symptomatic central nervous system metastasis

Any second malignancy active within the previous 5 years

Any active, known, or suspected autoimmune disease

Active or prior pneumonitis or interstitial lung disease

Trial design

Treatments tested in this trial

KM602

Treatment groups

38 Participants

are divided into 1 treatment group

Sponsors and collaborators

Xuanzhu Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov