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

NCT06175780 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2023-12-26

No results posted yet for this 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.

Conditions

  • Neoplasms
  • Neoplasms by Histologic Type

Interventions

DRUG

KY-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;

DRUG

KY-0118

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

DRUG

KY-0118

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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-28
Primary Completion
2025-12-28
Completion
2025-12-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175780 on ClinicalTrials.gov