Trial Title:
Phase 1 Trial of KH801
NCT ID:
NCT06364501
Condition:
Advanced Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KH801
Description:
KH801 is an injection solution
Arm group label:
Dose escalation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed informed consent voluntarily.
2. Age ≥ 18 years old (subject to the date of signing the informed consent form), both
genders.
3. With an expected life expectancy of ≥ 3 months.
4. With an ECOG（Eastern Cooperative Oncology Group Performance Status） performance
status score of 0-1.
5. 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.
6. 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.
7. 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).
8. 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.
9. 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.
Exclusion Criteria:
1. 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).
2. Patients with interstitial lung disease (ILD) (excluding local interstitial
pneumonia caused by radiotherapy), severe chronic obstructive pulmonary disease, and
severe pulmonary insufficiency.
3. 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.
4. Individuals who have previously received cluster of differentiation 24(CD24)
targeted therapy.
5. Previous history of receiving allogeneic hematopoietic stem cell transplantation or
other organ transplantation;
6. 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.
7. Participated in other clinical trials within 4 weeks prior to the first
administration.
8. Female subjects in lactation or pregnancy.
9. 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.
10. Active autoimmune diseases within the past 2 years (excluding vitiligo, Graves
disease, Hashimoto's thyroiditis, or psoriasis that do not require systemic
treatment).
11. 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.
12. 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).
13. 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.
14. Patients allergic to immunoglobulin or any component of KH801 injection.
15. Patients who have received live attenuated vaccine within 4 weeks before enrollment
or plan to receive live attenuated vaccine during the study period.
16. Patients who have undergone major surgery within 4 weeks before the first dose or
plan to have major surgery during the study period.
17. Patients who have any other conditions that render them inappropriate for inclusion
in the investigator's opinion.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Peking
Country:
China
Contact:
Last name:
Lin Shen
Investigator:
Last name:
Lin Shen
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
ErWei Song
Phone:
18982182468
Email:
022516@cnkh.com
Investigator:
Last name:
ErWei Song
Email:
Principal Investigator
Investigator:
Last name:
Junyan Wu
Email:
Principal Investigator
Investigator:
Last name:
Herui Yao
Email:
Principal Investigator
Facility:
Name:
Central Hospital Affiliated To Shandong First Medical University
Address:
City:
Jinan
Country:
China
Contact:
Last name:
Meili Sun
Investigator:
Last name:
Meili Sun
Email:
Principal Investigator
Facility:
Name:
West China Second University Hospital,Sichuan University/West China Women's and Children's Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Rutie Yin
Investigator:
Last name:
Rutie Yin
Email:
Principal Investigator
Start date:
September 1, 2024
Completion date:
May 1, 2030
Lead sponsor:
Agency:
Beijing Kanghong Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06364501
