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RecruitingNCT06175780Updated Dec 26, 2023

Phase I Study of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors

A Phase 1 interventional study of KY-0118 and KY-0118 in Neoplasms and Neoplasms by Histologic Type, sponsored by Novatim Immune Therapeutics (Zhejiang) Co., Ltd.. Recruiting at 8 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Dec 2022, registered Nov 2023).
  • Started Dec 2022; still recruiting 3 years 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
189
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This dose escalation and dose expansion study is to evaluate and characterize the tolerability, safety, pharmacokinetics and efficacy profile of single agent KY-0118 in Locally Advanced or Metastatic Solid Tumor Patients.

Read the detailed description

For Phase Ia It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with locally advanced or metastatic solid tumor patients , and determine the appropriate dose of KY-0118.

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.

02

Conditions studied

  • Neoplasms
  • Neoplasms by Histologic Type
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 189 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Novatim Immune Therapeutics (Zhejiang) Co., Ltd. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years old and ≤75 years old, male or female;
  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

Exclusion Criteria:

  1. Specific anti-tumor treatment prior to use of study treatment;
  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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
189 participants (estimated)

Study arms

  • Experimental
    KY-0118

    Drug: KY-0118

  • Experimental
    Cohort1: KY-0118

    Drug: KY-0118

  • Experimental
    Cohort2: KY-0118

    Drug: KY-0118

Interventions

  • DrugKY-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;

  • DrugKY-0118

    KY-0118 is to be injected intravenously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;

  • DrugKY-0118

    KY-0118 is to be injected subcutaneously with a dose of dose1\~dose5 weekly until disease progresses or unacceptable tolerability occurs;

06

What researchers measure

Primary outcomes

  1. Number of patients with dose-limiting toxicity (DLT)

    Time frame: 21 days during the first 3-week cycle

  2. Adverse Event

    Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAE Version 5.0.

    Time frame: Up to 28 days post last dose

Secondary outcomes

  1. Cmax

    Peak expansion

    Time frame: Up to 7 days post last dose

  2. Ctrough

    Trough concentration

    Time frame: Up to 7 days post last dose

  3. Tmax

    time to peak expansion

    Time frame: Up to 7 days post last dose

  4. T1/2

    Elimination half-life

    Time frame: Up to 7 days post last dose

  5. AUC

    Area under curve

    Time frame: Up to 7 days post last dose

  6. CL

    Clearance rate

    Time frame: Up to 7 days post last dose

  7. Regulatory t cells（Tregs）

    Levels of Tregs in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  8. CD4+ T lymphocyte count

    Levels of CD8+ T lymphocyte count in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  9. CD8+ T lymphocyte count

    Levels of CD8+ T lymphocyte count in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  10. NK cells count

    Levels of NK cells count in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  11. IL-6

    Levels of IL-6 in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  12. IFN-γ

    Levels of IFN-γ in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  13. TNF-ɑ

    Levels of TNF-ɑ in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  14. Granzyme B

    Levels of Granzyme B in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  15. Perforin

    Levels of perforin in peripheral blood at baseline and during administration;

    Time frame: Up to 7 days post last dose

  16. Objective response rate (ORR)

    To evaluate the preliminary antitumor activity of KY-0118

    Time frame: Up to 28 days post last dose

  17. Progression-free survival (PFS)

    To evaluate the preliminary antitumor activity of KY-0118

    Time frame: Up to 28 days post last dose

  18. Duration of response(DOR)

    To evaluate the preliminary antitumor activity of KY-0118

    Time frame: Up to 28 days post last dose

  19. Disease control rate (DCR)

    To evaluate the preliminary antitumor activity of KY-0118

    Time frame: Up to 28 days post last dose

  20. The incidence of ADA of KY-0118

    Each subject will be tested for anti-drug (KY-0118) antibody (ADA)

    Time frame: Up to 7 days post last dose

  21. The incidence of NAb of KY-0118

    Each subject with ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb)

    Time frame: Up to 7 days post last dose

  22. PD-1 receptor occupancy rate

    Time frame: Up to 7 days post last dose

  23. IL-2 receptor occupancy rate

    IL-2 receptor occupancy of Nk cells, CD8+ T lymphocyte and CD4+T lymphocyte

    Time frame: Up to 7 days post last dose

  24. Ki67 phenotype

    Ki67 phenotype of Nk cells and CD8+T lymphocyte

    Time frame: Up to 7 days post last dose

07

Study locations

7 of 8 sites recruiting
  • The First Affiliated Hospital Bengbu Medical College
    Bengbu, Anhui 233030, China
    Recruiting
  • The Fifth Medical Center of the Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • Guanghai Dai, professor · Contact · daigh60@sohu.com
    • Guanghai Dai, professor · Principal investigator
    • Lijun Chen, M.D. · Principal investigator
    Recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
    Recruiting
  • Hubei Province Tumor Hospital
    Wuhan, Hubei 430079, China
    • Xinjun Liang · Contact · Doctorlxj@163.com
    • Liang Xinjun, Doctor · Principal investigator
    Recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 276600, China
    • Benkang Shi, M.D. · Contact · bkang68@sdu.edu.cn
    • Benkang Shi, M.D. · Principal investigator
    • Shuwen Yu, M.D. · Principal investigator
    Recruiting
  • The Second People's Hospital of Liaocheng
    Liaocheng, Shandong 252000, China
    Recruiting
  • Tianjin Cancer Hospital
    Tianjin, Tianjin 300060, China
    • Yehui Shi · Contact · shiyehui@tom.com
    • Yehui Shi, M.D. · Principal investigator
    • Zhanyu Pan, Master · Principal investigator
    Recruiting
  • Zhejiang Province Tumor Hospital
    Hangzhou, Zhejiang, China
    • Meiyu Fang, M.D. · Contact · fangmy@zicc.org.cn
    • Meiyu Fang, M.D. · Principal investigator
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175780
Lead sponsor
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Responsible party
Sponsor
First posted
Dec 19, 2023
Start date
Dec 28, 2022
Primary completion
Dec 28, 2025 (estimated)
Completion
Dec 28, 2025 (estimated)
Last update
Dec 26, 2023

Study contacts

si li
Contact
s.li@novatim-zj.com
17879528905

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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