NCT06885645

First-In-Human Study in Participants With Advanced Solid Tumors

A Phase 1 Study of KH815 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chengdu Kanghong Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 Study of KH815 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients with Advanced Solid Tumors

Detailed description

The study will use BOIN design for dosing cohort management to determine the MTD and RDE/RP2D. The starting dose of KH815 is 0.5 mg/kg, followed by 1.0 to 4.0 mg/kg. The investigational product will be administered on Day 1 every 3 weeks via intravenous infusion, and the first cycle of KH815 treatment is for DLT evaluation. Enrolled patients will be sequentially assigned to the planned dose levels as required by the protocol and treated with KH815 IV Q3W to observe the occurrence of treatment related AEs and dose limiting toxicities. The dose-escalation decision will be determined per discussion between Safety Review Committee and Sponsor if deemed necessary. Moreover, the SRC is also responsible for deciding the MTD and the recommended dose level for dose-expansion study.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	KH815 for injection	KH815 for injection is a dual-payload Antibody Drug Conjugate (ADC) targeting TROP2 antigens.

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-03-20
• Last updated: 2025-04-03