NCT07514975

First-In-Human Study of KHN922 for Injection

A Phase 1/2 Study of KHN922 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 / Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Chengdu Kanghong Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1/2 Study of KHN922 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients with Advanced Solid Tumors

Detailed description

This study can be divided into two parts: Phase I - dose escalation and dose backfill ; Phase II - cohort-expansion.This study is expected to last approximately 3 years from the time the first participant is enrolled to the time the last participant is off the study. The longest treatment period for a participant in this study will be 24 months. Participants who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, Progressive disease (PD), or unacceptable toxicity may continue the study treatment until 24 months of treatment. Phase I:The primary endpoints is to assess the safety and tolerability of KHN922 in patients with advanced solid tumors.The Safety and tolerability will be evaluated by monitoring and assessment of AEs, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation, etc.), physical examination findings, and vital signs measurements to determine Recommended Dose for Phase 2 clinical trials (RP2D). Phase II:The primary endpoints is to assess the efficacy of KHN922.

Conditions

• Advanced Solid Tumors Cancer

Interventions

Type	Name	Description
DRUG	KHN922 for injection	KHN922 for injection is a dual-payload Antibody Drug Conjugate (ADC) targeting HER3 antigens，intravenous (IV) administration every three weeks (D1) .

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2026-04-07
• Last updated: 2026-04-09

Locations

1 site across 1 country: China