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Advanced Solid Tumors CancerPhase 1/2NCT07514975

First-In-Human Study of KHN922 for Injection

A Phase 1/2 study testing KHN922 for injection in people with Advanced Solid Tumors Cancer, run by Chengdu Kanghong Biotech Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
KHN922 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteChina
Study dates
Apr 2026to Apr 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 1.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).
Show all 22Show fewer
  • 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.
  • 4.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%).
  • 6.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.
  • 8.Grade ≥2 anorexia, nausea, vomiting, or diarrhea within 2 weeks prior to first infusion of KHN922.
  • 9.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.
  • 10.History of significant active bleeding, intestinal obstruction, gastrointestinal perforation, or other severe gastrointestinal diseases within 6 months prior to first infusion of KHN922.
  • 11.Newly diagnosed thromboembolic events requiring treatment within 6 months prior to first infusion of KHN922.
  • 12.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).
  • 13.Known to be allergic to any component of KHN922, or known history of grade ≥3 anaphylaxis to macromolecular protein products/antibody-based therapy, or known history of grade ≥3 drug-related AEs with the use of topoisomerase I inhibitors such as irinotecan.
  • 14.Patients who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to the first infusion of KHN922 and throughout study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this study.
  • 15.Positive for Human Immunodeficiency Virus (HIV) antibody; active Hepatitis B Virus (HBV) [subjects with positive HBsAg or HBcAb in this study need to be tested for HBV DNA, and if HBV DNA > 500 IU/mL (or 2500 copies/ml), they will be excluded. For subjects with positive HBsAg or HBcAb, it is allowed to receive antiviral treatment until HBV-DNA reaches ≤ 500 IU/ml (or 2500 copies/ml) before enrollment in the study]; positive for HCV antibody and HCV-RNA above the lower limit of measurability or 1000 copies/mL (whichever is lower); subjects with untreated or currently treated tuberculosis as diagnosed through inquiry.
  • 16.Known history of allogeneic cell or solid organ transplantation. 17.Active infection requiring systemic treatment within 2 weeks prior to the first infusion of KHN922.
  • 18.Confirmed Gilbert's syndrome 19.Live or live attenuated vaccine within 28 days prior to KHN922 administration and live or live attenuated vaccine planned over the course of the study.
  • 20.Known history of psychotropic substance abuse, alcohol abuse, or drug abuse. 21.Psychological, social, familial, or geographical factors that would prevent regular follow-up. Adults under guardianship, curatorship, safeguard of justice, or family empowerment measure are not eligible.
  • 22.Otherwise considered inappropriate for the study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erwei Song, MD contact

+86-020-81332507

songew@mail.sysu.edu.cn

Herui Yao,MD contact

+86-020-81332507

yaoherui@163.com

China1 site

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

    Guangzhou, Guangdong, 510120

    Erwei Song, MD, +86-020-81332507, songew@mail.sysu.edu.cn

    Herui Yao,MD, +86-020-81332507, yaoherui@163.com

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
KHN922 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KHN922 for injectionDrug

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

Study groups in NCT07514975
Study groupRoleWhat they receive
Phase I KHN922 for InjectionExperimentalExperimental: Phase I part of the study: 0.8~8.0 mg/kg of KHN922 for injection
Receives: Drug: KHN922 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLTs)

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

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

  2. 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.

    Measured: up to 12 months

Secondary outcomes (2)

  1. Maximum plasma concentration (Cmax)

    To evaluate the systemic pharmacokinetics of KHN922 in subjects.

    Measured: through study completion, an average of 1 year

  2. ADA prevalence and incidence

    To assess the prevalence and incidence of anti-drug antibody (ADA) of KHN922

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514975
Sponsor's protocol ID
KHN922-30101
Status last verified
Apr 2026
First submitted
23 Mar 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KHN922 for injection in people with Advanced Solid Tumors Cancer, run by Chengdu Kanghong Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erwei Song, MD (+86-020-81332507, songew@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07514975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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