KM602: 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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)
2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1
3. ECOG performance status of 0 or 1
4. Life expectancy of ≥ 12 weeks
5. Adequate baseline hematologic, renal, and hepatic function
Exclusion Criteria:
1. Patients with meningeal metastasis or symptomatic central nervous system metastasis
2. Any second malignancy active within the previous 5 years
3. Any active, known, or suspected autoimmune disease
4. Active or prior pneumonitis or interstitial lung disease
5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation
6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602
7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
9. Systemic treatment with corticosteroids (\> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study
10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C
11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation
12. Active infection requiring therapy at the time of the first dose of KM602
13. Pregnancy or breastfeeding
14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
Primary outcome measure(s)
Maximum tolerated dose (MTD) of KM602, if any — Approximately 15 months Determined by the frequency of dose-limiting toxicities during dose-escalation
Recommended Phase 2 dose (RP2D) of KM602 — Approximately 15 months Determined by the frequency of dose-limiting toxicities during dose-escalation
Incidence of treatment emergent adverse events — Through study completion, approximately 28 months Severity graded per CTCAE version 5.0
Trial sites (1)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
More Xuanzhu Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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