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Advanced Solid TumorsPhase 1NCT06885645

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

A Phase 1 study testing KH815 for injection in people with Advanced Solid Tumors, run by Chengdu Kanghong Biotech Co., Ltd..

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
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
KH815 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
30 Apr 2025to 31 Dec 2027
Phase
Phase 1
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

  • Signed, written IRB-approved Informed Consent.
  • Male or female.
  • Aged 18 ~ 75 years.
  • Life expectancy of at least 3 months.
  • Histologically or cytologically confirmed advanced or unresectable solid tumors for wihch failure or difficult to be treated with standard therapies, or not suitable for standard therapies.
  • Measurable disease by CT/MRI as defined in RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Who cannot join

  • Pregnant or lactating women.
  • 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.
Show all 29Show fewer
  • Chemotherapy (including non-antibody based immunotherapy therapy) within 2 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 2 weeks.
  • Tyrosine kinase inhibitor (TKI) treatment within 1 week.
  • Received experimental drug therapy or participated in a clinical study of a medical device within 4 weeks prior to first infusion of KH815.
  • 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
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and/or diabetes (HbA1c ≥ 9.0%).
  • Uncontrolled pleural effusion or pericardial effusion. Ascites requiring repeated drainage surgery (once a month or more frequently).
  • 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 history 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 KH815.
  • 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 KH815.
  • History of significant active bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months prior to first infusion of KH815.
  • Newly diagnosed thromboembolic events requiring treatment within 6 months prior to first infusion of KH815 [patients with controlled and stable lower extremity deep venous thrombosis (DVT) or catheter related thrombosis (CRT) could be included].
  • Known history of other malignancies diagnosed within 5 years prior to first infusion of KH815 (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).
  • Known history of severe dry eye, severe meibomian gland disease or blepharitis, incurable or delayed corneal healing resulted from the keratopathy or macular disease.
  • Known to be allergic to any component of KH815, 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.
  • Patients who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to the first infusion of KH815 and throughout study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this study.
  • Human immunodeficiency virus (HIV) antibody positive. Has an active or uncontrolled hepatitis B (HBV) and/or hepatitis C (HCV) infection. Patients with untreated or ongoing tuberculosis, but those who have undergone standard anti-tuberculosis treatment and have been confirmed as cured by the investigator could be included.
  • Known history of allogeneic cell or solid organ transplantation.
  • Active infection requiring systemic treatment within 2 weeks prior to the first infusion of KH815.
  • Live or live attenuated vaccine within 28 days prior to KH815 administration and live or live attenuated vaccine planned over the course of the study.
  • Known history of psychotropic substance abuse, alcohol abuse, or drug abuse.
  • 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.
  • Otherwise considered inappropriate for the study by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fei Ma, Dr. contact

+86 10 87788114

drmafei@126.com

About this study

Official title: 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

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

Read the 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.

Being tested
KH815 for injection

What participants receive

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

  • KH815 for injectionDrug

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

Study groups in NCT06885645
Study groupRoleWhat they receive
KH815 for InjectionExperimentalPhase I: Dose Escalation Phase I part of the study:dose1-dose5 of KH815 for injection
Receives: Drug: KH815 for injection

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    To determine the maximum tolerated dose (MTD)

    Measured: Postdose of last participant up to 12 months

  2. Dose Limiting Toxicities (DLTs)

    To determine the Dose Limiting Toxicities (DLTs).

    Measured: Baseline up to 21 days after the first dose

  3. Recommended Doses for Expansion (RDEs)

    To determine the recommended doses for expansion (RDEs).

    Measured: Postdose of last participant up to 12 months

Secondary outcomes (7)

  1. Cmax

    To characterize the Cmax of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.

    Measured: Post last dose up to Day 60

  2. Tmax

    To characterize the Tmax of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.

    Measured: Post last dose up to Day 60

  3. AUC0-t

    To characterize the AUC0-t of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.

    Measured: Post last dose up to Day 60

  4. AUCtau

    To characterize the AUCtau of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.

    Measured: Post last dose up to Day 60

  5. t1/2

    To characterize the t1/2 of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.

    Measured: Post last dose up to Day 60

  6. Objective Response Rate (ORR)

    To evaluate the objective response rate (ORR) of KH815 for injection when administered intravenously (IV) as monotherapy at the RDEs to patients with advanced solid tumors.

    Measured: Postdose of last participant up to 12 months

  7. Phase I: ADA prevalence and incidence

    To assess the prevalence and incidence of anti-drug antibody (ADA) of KH815

    Measured: Post last dose up to Day 60

Timeline

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

  1. First posted20 Mar 2025
  2. Study start30 Apr 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885645
Sponsor's protocol ID
KH815-30101
Status last verified
Mar 2025
First submitted
6 Mar 2025
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KH815 for injection in people with Advanced Solid Tumors, run by Chengdu Kanghong Biotech Co., Ltd..

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 7 inclusion and 29 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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 Fei Ma, Dr. (+86 10 87788114, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Postdose of last participant up to 12 months). The study lists 3 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 NCT06885645.

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 3 Apr 2025.

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