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NOT YET RECRUITING
NCT06928363
PHASE1/PHASE2

A First-in-human Study of KY-0301 in Patients With Advanced Solid Tumors.

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

View on ClinicalTrials.gov

Summary

This trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. This trial will be conducted at approximately multi-sites nationwide, and approximately110\~212 participants with unresectable locally advanced or metastatic solid tumors will be invited to participate. The study consists of three parts: Phase I dose escalation \& dose expansion phases of KY-0301 as monotherapy, Phase II cohort expansion phase of KY-0301 as monotherapy.

Official title: A First-in-human, Multicenter, Open-label Phase I/II Investigational Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KY-0301 as Monotherapy in Patients With Advanced Solid Tumors.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2025-05-01

Completion Date

2027-12-15

Last Updated

2025-04-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

KY-0301

KY-0301 is an antibody-drug conjugate (ADC) targeting both EGFR and c-Met, developed independently by Novatim Immune Therapeutics (Zhejiang) Co., Ltd