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

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.8 sites in 1 country189 target enrollmentDecember 28, 2022

ConditionsNeoplasms Neoplasms by Histologic Type

InterventionsKY-0118

DrugsKY-0118

Overview

Phase: Phase 1
Intervention: KY-0118
Conditions: Neoplasms
Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Enrollment: 189
Locations: 8
Primary Endpoint: Number of patients with dose-limiting toxicity (DLT)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

December 28, 2022

End Date

December 28, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Arms & Interventions

KY-0118

Intervention: KY-0118

Cohort1: KY-0118

Intervention: KY-0118

Cohort2: KY-0118

Intervention: KY-0118

Outcomes

Primary Outcomes

Number of patients with dose-limiting toxicity (DLT)

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

Adverse Event

Time Frame: Up to 28 days post last dose

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.