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Trial Title:
A Study of KM602 in Patients With Advanced Solid Tumors
NCT ID:
NCT05766527
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KM602
Description:
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.
Arm group label:
KM602 monotherapy
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.
Detailed description:
This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy.
Monotherapy dose escalation is designed with initial accelerated titration followed by a
standard 3+3 dose escalation; Patients will remain on study treatment until progression
of disease, unacceptable toxicity, or other specified reason for discontinuation.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Jun Guo
Phone:
13911233048
Email:
guoj307@126.com
Start date:
April 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Xuanzhu Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Xuanzhu Biopharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766527
