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Advanced Solid TumorsPhase 1NCT06364501

Phase 1 Trial of KH801

A Phase 1 study testing KH801 in people with Advanced Solid Tumors, run by Beijing Kanghong Biopharmaceutical Co., Ltd. at 4 sites 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

KH801 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Or 0.9% sodium chloride Injection. This study is expected to include a total of approximately 17-42 participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
KH801
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
4 sitesChina
Study dates
1 Sep 2024to 1 May 2030
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent voluntarily.
  • Age ≥ 18 years old (subject to the date of signing the informed consent form), both genders.
  • With an expected life expectancy of ≥ 3 months.
  • With an ECOG（Eastern Cooperative Oncology Group Performance Status） performance status score of 0-1.
  • Patients with locally advanced unresectable or metastatic malignant solid tumors confirmed by histology, (including but not limited to breast cancer, lung cancer, ovarian cancer, colorectal cancer and other solid tumors) who failed or unable to tolerate previous standard treatments.
  • With at least one measurable target lesion was evaluated according to RECIST v1.1 criteria. Measurable target lesions were defined as non-lymph node lesions with the longest single diameter ≥ 10mm, or lymph node lesions with a short diameter ≥ 15mm.
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  • The organ function reserve of patients before enrollment should meet the following laboratory test values:
  • 7.1 Hematology: Neutrophil count ≥ 1.5 × 109/L, hemoglobin ≥ 90g/L, platelets ≥ 100 × 109/L ( Use of hematopoietic growth factor drugs within the first two weeks of screening is not allowed to improve the detection value and meet inclusion criteria); 7.2 Liver function: Total bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (if there is liver metastasis or hepatocellular carcinoma(HCC), ALT and AST ≤ 5 x ULN); 7.3 Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 milliliter（mL)/min (calculated using Cockcroft Gault formula, see Appendix 5 for details); Urinary protein<2+, or urinary protein ≥ 2+and 24-hour urine protein quantification<1g; 7.4 Coagulation function: prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (except for patients receiving anticoagulant therapy).
  • Female patients with fertility or male patients with partners with fertility must start using efficient contraceptive measures 7 days before the first dose and continue until 6 months after the last dose (excluding those who have undergone sterilization surgery (such as bilateral tubal ligation, oophorectomy, or hysterectomy). Female patients with fertility must have a negative blood pregnancy test within 7 days before the first administration.
  • Patients must recover from acute toxic reactions caused by previous anti-tumor treatments (CTCAE ≤ level 1), except for the following situations: a. hair loss; b. Skin pigmentation; c. Grade 2 ande below neurotoxicity; d. The long-term toxicity caused by radiotherapy cannot be restored according to the judgment of the researchers.

Who cannot join

  • Patients with primary central nervous system tumors and central nervous system (CNS) metastases (except for patients who have been clinically stable for ≥ 4 weeks after previous surgery or radiotherapy and have discontinued corticosteroid treatment).
  • Patients with interstitial lung disease (ILD) (excluding local interstitial pneumonia caused by radiotherapy), severe chronic obstructive pulmonary disease, and severe pulmonary insufficiency.
  • Positive for human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBV-DNA copy number ≥ ULN) or active hepatitis C virus infection (HCV-RNA ≥ ULN), as well as other severe active infections that have not been controlled or require treatment.
  • Individuals who have previously received cluster of differentiation 24(CD24) targeted therapy.
  • Previous history of receiving allogeneic hematopoietic stem cell transplantation or other organ transplantation;
  • Patients who have received any anti-tumor treatment (including chemotherapy, hormone therapy, radiotherapy, immunotherapy, or biological therapy) within 4 weeks or 5 half lives of drugs previously used (whichever is longer) before the first dose.
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  • Participated in other clinical trials within 4 weeks prior to the first administration.
  • Female subjects in lactation or pregnancy.
  • Previous or current mental/neurological disorders are not limited to schizophrenia, delusions, phobias, obsessive-compulsive disorder, Alzheimer's disease, behavioral and volitional disorders, postpartum mental disorders, paranoid mental disorders, and various organic disorders accompanied by mental disorders.
  • Active autoimmune diseases within the past 2 years (excluding vitiligo, Graves disease, Hashimoto's thyroiditis, or psoriasis that do not require systemic treatment).
  • Have suffered from other malignant tumors within the past 5 years, except for the following situations:
  • 11.1 Cured non melanoma skin malignant tumors; 11.2 Cervical carcinoma in situ; 11.3 Cured stage I endometrial cancer; 11.4 Curative breast ductal carcinoma in situ or lobular carcinoma in situ, and currently not receiving any systemic treatment; 11.5 Localized prostate cancer, papillary thyroid cancer, or follicular thyroid cancer that has undergone radical surgery and is currently considered cured/long-term stable.
  • Accompanied by active cardiovascular and cerebrovascular diseases:
  • 12.1 Has experienced myocardial infarction, stroke, bypass surgery, or stent placement within 6 months prior to the first administration; 12.2 Congestive heart failure New York Heart Association(NYHA) III-IV; 12.3 Left ventricular ejection fraction (LVEF)<50%; 12.4 Corrected QT interval(QTC) was prolonged (female>470ms, male>450ms); 12.5 Unstable angina that cannot be controlled by medication, severe arrhythmias that require medication treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia); 12.6 Hypertension (systolic blood pressure ≥ 160 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 100mmHg) that cannot be controlled after standardized drug treatment, as well as a history of hypertensive crisis or hypertensive encephalopathy; 12.7 Suffering from major vascular diseases (such as aortic aneurysm, aortic dissection).
  • Patients with deep vein thrombosis (except for those with stable intermuscular vein thrombosis or infusion port thrombosis assessed by the investigators), pulmonary embolism or other serious thromboembolism, or patients with deep vein thrombosis, pulmonary embolism or other serious thromboembolism within 6 months before enrollment, and who are assessed by the investigator to be at risk of recurrence.
  • Patients allergic to immunoglobulin or any component of KH801 injection.
  • Patients who have received live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period.
  • Patients who have undergone major surgery within 4 weeks before the first dose or plan to have major surgery during the study period.
  • Patients who have any other conditions that render them inappropriate for inclusion in the investigator's opinion.

Trial locations and contacts

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

Erwei Song contact

18982182468

022516@cnkh.com

Ling Song contact

028-87516210

songlin@cnkh.com

China4 sites

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

    Lin Shen

    Lin Shen

  • West China Second University Hospital,Sichuan University/West China Women's and Children's Hospital

    Chengdu, Sichuan, 610000

    Rutie Yin

    Rutie Yin

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

    Guangzhou, Guangdong

    ErWei Song, 18982182468, 022516@cnkh.com

    ErWei Song

  • Central Hospital Affiliated To Shandong First Medical University

    Jinan, Shandong

    Meili Sun

    Meili Sun

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Activity of KH801 Injection in Patients With Advanced Solid Tumors

KH801 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Or 0.9% sodium chloride Injection.

This study is expected to include a total of approximately 17-42 participants.

Being tested
KH801

What participants receive

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

  • KH801Drug

    KH801 is an injection solution

Study groups in NCT06364501
Study groupRoleWhat they receive
Dose escalationExperimentalKH801 will be sequentially escalated at the dose of 0.01 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg , 3.0 mg/kg, 6.0 mg/kg , 10.0 mg/kg, administered via intravenous infusion every 2 weeks in 28-day treatment cycles.
Receives: Drug: KH801

What is being measured

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

  1. MTD

    Maximum tolerated dose (MTD)

    Measured: up to 4 weeks

  2. DLT

    Dose limiting toxicity (DLT)

    Measured: up to 4 weeks

  3. RP2D

    Recommended phase II dose (RP2D)

    Measured: up to 1 year

Secondary outcomes (8)

  1. AE

    Adverse events

    Measured: 30 days after EOT,up to 1 year

  2. Cmax

    Maximum serum concentration (Cmax) of KH801 will be investigated

    Measured: up to 12 weeks

  3. Tmax

    Time to maximum serum concentration(Tmax) of KH801 will be investigated

    Measured: up to 12 weeks

  4. T1/2

    Half-life (T1/2) of KH801 will be investigated

    Measured: up to 12 weeks

  5. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration

    Measured: up to 12 weeks

  6. CL

    Plasma clearance rate (Cl) is defined the volume of plasma per unit time in which drugs are completely eliminated.

    Measured: up to 12 weeks

  7. AUC0-inf

    AUC0-inf is defined area under the blood drug concentration time curve from 0 to infinity

    Measured: up to 12 weeks

  8. anti-drug antibody (ADA)

    The anti-drug antibody of KH801

    Measured: up to 1 years

Timeline

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

  1. First posted15 Apr 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2030 (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
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06364501
Sponsor's protocol ID
KH801
Status last verified
Apr 2024
First submitted
2 Apr 2024
Last updated
7 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KH801 in people with Advanced Solid Tumors, run by Beijing Kanghong Biopharmaceutical Co., Ltd. at 4 sites 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 10 inclusion and 19 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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 Erwei Song (18982182468, 022516@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: up to 4 weeks). 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 NCT06364501.

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 7 Aug 2024.

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