Evaluating KY-0118 for advanced solid tumors

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors

This study is testing a new drug called KY-0118 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 189 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (industry)
• Drugs / interventions: immunotherapy
• Locations: 8 sites (Bengbu, Anhui and 7 other locations)
• Trial ID: NCT06175780 on ClinicalTrials.gov

What this trial studies

This Phase I study investigates the safety, tolerability, pharmacokinetics, and efficacy of KY-0118 in patients with locally advanced or metastatic solid tumors. The study is divided into two phases: Phase Ia focuses on determining the appropriate dose and assessing the drug's pharmacodynamic effects, while Phase Ib further evaluates efficacy and safety across multiple dose groups. Participants will receive KY-0118 and be monitored for their response and any side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced or metastatic solid tumors that have progressed or are intolerant to existing therapies.

Not a fit: Patients with specific prior anti-tumor treatments or those currently on immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar immunotherapeutic approaches, but this specific treatment is novel.

Eligibility 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.

Where this trial is running

Bengbu, Anhui and 7 other locations

• The First Affiliated Hospital Bengbu Medical College — Bengbu, Anhui, China (RECRUITING)
• The Fifth Medical Center of the Chinese PLA General Hospital — Beijing, Beijing, China (RECRUITING)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)
• Hubei Province Tumor Hospital — Wuhan, Hubei, China (RECRUITING)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
• The Second People's Hospital of Liaocheng — Liaocheng, Shandong, China (RECRUITING)
• Tianjin Cancer Hospital — Tianjin, Tianjin, China (RECRUITING)
• Zhejiang Province Tumor Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: si li

Conditions: Neoplasms, Neoplasms by Histologic Type