First-In-Human Study of KHN922 for Injection

NCT07514975 | Not Yet Recruiting Phase 1

• 1 other identifier: KHN922-30101
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Solid Tumors Cancer

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities (DLTs)

  To evaluate the safety and tolerability of KHN922 to determine the dose and schedule to be used in phase 1

  At the end of Cycle 1 (each cycle is 21 days)

• Objective Response Rate (ORR)

  To evaluate the objective response rate (ORR) of KHN922 for injection when administered intravenously (IV) as monotherapy at the RP2D to patients with advanced solid tumors.

  up to 12 months

Secondary Outcomes (2)

• Maximum plasma concentration (Cmax)

  through study completion, an average of 1 year

• ADA prevalence and incidence

  through study completion, an average of 1 year

Study Arms (1)

Phase I KHN922 for Injection

EXPERIMENTAL

Experimental: Phase I part of the study: 0.8\~8.0 mg/kg of KHN922 for injection

Drug: KHN922 for injection

Interventions

KHN922 for injection DRUG

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

Phase I KHN922 for Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Measurable disease by CT/MRI as defined in RECIST v1.1. 7.Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

You may not qualify if:

• Pregnant or lactating women. 2.Received cancer-directed therapy within the following timeframes:
• Major surgery within 4 weeks or will be expected to require major surgical treatment during the study period.
• Radical radiotherapy or chest palliative radiotherapy within 4 weeks, or palliative radiotherapy at any other sites except chest within 2 weeks.
• Antibody-based anti-cancer therapies, macromolecular protein products or cytotherapies within 4 weeks.
• Hormonal anti-tumor therapy within 2 weeks.
• Chemotherapy (including non-antibody based immunotherapy therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 times half life of the chemotherapeutic agent (whichever is longer).
• Any natural medicine with anti-tumor effect within 1 weeks.
• Tyrosine kinase inhibitor (TKI) treatment within 1 week. 3.Received experimental drug therapy or participated in a clinical study of a medical device within 4 weeks prior to first infusion of KHN922.
• Known history of unstable angina, myocardial infarction (MI), or congestive heart failure (CHF) (NYHA Class II-IV) within 6 months or clinically significant arrhythmia (other than stable atrial fibrillation or paroxysmal superventricular tachycardia) requiring anti-arrhythmia therapy 5.Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and/or diabetes (HbA1c ≥ 8.0%).
• serous cavity effusion such as ascites or pleural effusion requiring drainage within 14 days before the first dose of medication. 7.Patients with moderate to severe respiratory dyspnea due to severe primary lung disease or complications of advanced malignancy \[rated as grade 3/4 by modified Medical Research Council (mMRC) scale\] (see Appendix 3), or requiring continuous oxygen therapy, or acute exacerbations of chronic obstructive pulmonary disease (AECOPD), or current abnormal and clinically significant of interstitial lung disease (ILD)/pneumonia, or ILD/ pneumonia that could not be ruled out on imaging during screening, or any autoimmune disease/connective tissue disease (e.g. Rheumatoid arthritis, Sjogren's syndrome, sarcoidosis) with lungs involvement.
• Grade ≥2 anorexia, nausea, vomiting, or diarrhea within 2 weeks prior to first infusion of KHN922.
• Active central nervous system (CNS) metastasis (defined as untreated and has symptoms such as consciousness disorder, or need steroid or anticonvulsant therapy to control symptoms) within 1 month prior to first infusion of KHN922.
• History of significant active bleeding, intestinal obstruction, gastrointestinal perforation, or other severe gastrointestinal diseases within 6 months prior to first infusion of KHN922.
• Newly diagnosed thromboembolic events requiring treatment within 6 months prior to first infusion of KHN922.
• Known history of other malignancies diagnosed within 5 years prior to first infusion of KHN922 (patients with basal cell carcinoma, skin squamous cell carcinoma and carcinoma in situ, and with radical resection for more than 3 years could be enrolled).

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Qing Zhou

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Yan Zhang

  Shandong Cancer Hospital&Institute

  PRINCIPAL INVESTIGATOR

• Xin Wang

  Shanxi Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erwei Song, MD

CONTACT

+86-020-81332507; songew@mail.sysu.edu.cn

Herui Yao,MD

CONTACT

+86-020-81332507; yaoherui@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)