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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

KM602
Biological/Vaccine
Multiple dose levels of KM602 will be administered, including 0.01 mg/kg QW, 0.1 mg/kg QW, 0.6 mg/kg QW, 3 mg/kg QW, and 10 mg/kg QW. KM602 is administered intravenously once a week, and each cycle is 21 days.

Treatment groups

38 Participants

are divided into 1 treatment group

Group A: KM602 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum tolerated dose (MTD) of KM602, if any

Determined by the frequency of dose-limiting toxicities during dose-escalation

Time frame

Approximately 15 months

Recommended Phase 2 dose (RP2D) of KM602

Determined by the frequency of dose-limiting toxicities during dose-escalation

Time frame

Approximately 15 months

Incidence of treatment emergent adverse events

Severity graded per CTCAE version 5.0

Time frame