Phase I Study of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT06175780
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
189 participants
INTERVENTIONAL
2022-12-28
2025-12-28
Brief Summary
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Detailed Description
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For Phase Ib it aims is to further evaluate the efficacy, safety, tolerability, pharmacokinetic properties, pharmacodynamic effects and immunogenicity of KY-0118 with appropriate dose groups (approximately 3-5 dose groups) in different Administration manner.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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KY-0118
KY-0118
KY-0118 is to be injected intravenously with a dose of 0.3μg/kg, 1μg/kg, 3μg/kg, 6μg/kg, 12μg/kg, 24μg/kg, 36μg/kg, 48μg/kg or 64μg/kg until disease progresses or unacceptable tolerability occurs;
Cohort1: KY-0118
KY-0118
KY-0118 is to be injected intravenously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;
Cohort2: KY-0118
KY-0118
KY-0118 is to be injected subcutaneously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;
Interventions
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KY-0118
KY-0118 is to be injected intravenously with a dose of 0.3μg/kg, 1μg/kg, 3μg/kg, 6μg/kg, 12μg/kg, 24μg/kg, 36μg/kg, 48μg/kg or 64μg/kg until disease progresses or unacceptable tolerability occurs;
KY-0118
KY-0118 is to be injected intravenously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;
KY-0118
KY-0118 is to be injected subcutaneously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;
Eligibility Criteria
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Inclusion Criteria
2. Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; progression or are intolerant to existing standard therapy or subjects without standard therapy;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；Expected survival time≥ 12 weeks;
4. At least one measurable lesion per RECIST 1.1 (without local treatment or progress after local treatment);
5. Adequate organ function;
6. Toxicity from prior anticancer therapy recovered to ≤ grade 1 prior to the first dose of study drugs;
7. Signed informed consent and willingly adherence to the experimental treatment protocol and visit plan.
Exclusion Criteria
2. Immunosuppressants or systemic hormone therapy were being used and were not discontinued within 2 weeks prior to enrollment;
3. IL-2 treatment within 6 months prior to the first dose of study drugs;
4. Any immune related adverse events (irAE) that have occurred during previous immunotherapy medication, with a grade of ≥ 3 or leading to termination of immunotherapy;
5. Primary Central Nervous System (CNS) Malignant Tumors or Active CNS Metastasis with Local Treatment Failure;
6. Any severe and/or uncontrolled diseases, including but not limited to: uncontrolled hypertension or pulmonary hypertension or unstable angina; Chronic heart failure; Valve disease; Severe arrhythmia; Had myocardial infarction or bypass or stent surgery within 6 months before screening;
7. History of arteriovenous thromboembolism within 6 months prior to screening；
8. Moderate or severe respiratory distress at rest due to advanced malignant tumors or their complications or severe primary lung diseases；or a current need for continuous oxygen therapy, or a current history of interstitial lung disease (ILD) or pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. ;
9. Uncontrolled bleeding or known tendency to bleed; Patients with chronic Crohn's disease and ulcerative colitis;Patients with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome;Patients with a history of intestinal perforation and fistula, but not cured after surgical treatment;Esophagogastric varices;
10. Third space effusion that cannot be controlled by puncture and drainage treatment and require repeated drainage or have obvious symptoms;
11. Patients who require extensive fluid replacement assessed by investigators;
12. Active hepatitis B or active hepatitis C;
13. Active infectious process;
14. A history of immunodeficiency;
15. Autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, autoimmune thyroid disease, multiple sclerosis, etc.;
16. Patients with allergic constitution, or known to have a history of allergy to IL-2 or PD-1/PD-L1 drugs or any of their components, or known to have a history of severe allergic reactions to fusion proteins;
17. History of other malignancies within 5 years prior to screening;
18. Surgery (other than diagnostic biopsy) within 4 weeks prior to screening or planned to have surgery during the study period;
19. Had received live vaccine within 4 weeks before the first dose or planned to receive live vaccine during the trial;
20. History of neurological or psychiatric disorders, such as epilepsy, dementia, altered mental status, and poor compliance;
21. History of alcohol or drug abuse within the last 1 year;
22. Women who are pregnant or breastfeeding. Patients unwilling to use a highly effective method of contraception during the study period and for 6 months after receiving the trial drug;
23. Attended other study within 4 weeks prior to screening;
24. Other conditions deemed unsuitable for inclusion by the investigators.
18 Years
75 Years
ALL
No
Sponsors
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Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Hubei Province Tumor Hospital
Wuhan, Hubei, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Second People's Hospital of Liaocheng
Liaocheng, Shandong, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Province Tumor Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Huan Zhou
Role: primary
Guanghai Dai, professor
Role: primary
Yu Chen, M.D.
Role: primary
Xinjun Liang
Role: primary
Benkang Shi, M.D.
Role: primary
Yanjun Wang, M.D.
Role: primary
Yehui Shi
Role: primary
Meiyu Fang, M.D.
Role: primary
Other Identifiers
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KY-0118-ZJKY
Identifier Type: -
Identifier Source: org_study_id