NCT06928363

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-11-12
• Completion: 2027-12-15
• First posted: 2025-04-15
• Last updated: 2025-04-15

Regulatory

• FDA-regulated drug study