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

NCT06175780 | Unknown Phase 1 DMC

• 1 other identifier: KY-0118-ZJKY
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Neoplasms; Neoplasms by Histologic Type

Outcome Measures

Primary Outcomes (2)

• Number of patients with dose-limiting toxicity (DLT)

  21 days during the first 3-week cycle

• 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.

  Up to 28 days post last dose

Secondary Outcomes (24)

• Cmax

  Up to 7 days post last dose

• Ctrough

  Up to 7 days post last dose

• Tmax

  Up to 7 days post last dose

• T1/2

  Up to 7 days post last dose

• AUC

  Up to 7 days post last dose

Study Arms (3)

KY-0118

EXPERIMENTAL

Drug: KY-0118

Cohort1: KY-0118

EXPERIMENTAL

Drug: KY-0118

Cohort2: KY-0118

EXPERIMENTAL

Drug: KY-0118

Interventions

KY-0118 DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤75 years old, male or female;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；Expected survival time≥ 12 weeks;
• At least one measurable lesion per RECIST 1.1 (without local treatment or progress after local treatment);
• Adequate organ function;
• Toxicity from prior anticancer therapy recovered to ≤ grade 1 prior to the first dose of study drugs;
• Signed informed consent and willingly adherence to the experimental treatment protocol and visit plan.

You may not qualify if:

• Specific anti-tumor treatment prior to use of study treatment;
• Immunosuppressants or systemic hormone therapy were being used and were not discontinued within 2 weeks prior to enrollment;
• IL-2 treatment within 6 months prior to the first dose of study drugs;
• Any immune related adverse events (irAE) that have occurred during previous immunotherapy medication, with a grade of ≥ 3 or leading to termination of immunotherapy;
• Primary Central Nervous System (CNS) Malignant Tumors or Active CNS Metastasis with Local Treatment Failure;
• 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;
• History of arteriovenous thromboembolism within 6 months prior to screening；
• 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. ;
• 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;
• Third space effusion that cannot be controlled by puncture and drainage treatment and require repeated drainage or have obvious symptoms;
• Patients who require extensive fluid replacement assessed by investigators;
• Active hepatitis B or active hepatitis C;
• Active infectious process;
• A history of immunodeficiency;
• 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.;

Sponsors & Collaborators

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

Study Sites (8)

The First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, 233030, China

RECRUITING

The Fifth Medical Center of the Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Hubei Province Tumor Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 276600, China

RECRUITING

The Second People's Hospital of Liaocheng

Liaocheng, Shandong, 252000, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Zhejiang Province Tumor Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasms by Histologic Type

Central Study Contacts

si li

CONTACT

17879528905; s.li@novatim-zj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 19, 2023
• Study Start: December 28, 2022
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (8)