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

• Status: Recruiting
• Trial end date: 2025-12-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Criteria

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:

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.