Beijing Titan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
Location contact
Wenbin Li, M.D.
CONTACT
NCT Number: NCT05667194
KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100000, China
Location status: Recruiting
Wenbin Li, M.D.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2.Patient is male or female ≥18 years of age. 3.Patient must satisfy the following laboratory test results:
a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10^9/L c.Absolute neutrophil count≥1.5×10^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function, defined as estimated serum creatinine clearance>50mL/minute calculated using the Cockcroft-Gault equation,urine protein<2+ or urine protein>2+ but 24-hour proteinuria<1g h.Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment.
5.Life expectancy at least 3 months. 6.Specific Inclusion Criteria
Exclusion criteria
a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis B b.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolled active infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration (only for female with bearing potential ), or male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617.
KH617 is s freeze-dried powder injection
Time frame: 90 weeks
Time frame: 90 weeks
Time frame: 154 weeks
Time frame: 154 weeks
Time frame: 154 weeks
Contact information is provided by the study sponsor or research team.
Zhao Manxi
CONTACT
Ziyun Gan
CONTACT
Sichuan Honghe Biotechnology Co., Ltd.
Industry
A Phase 1 Study to Assess the Safety ,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of KH617 After SAD and MAD Administration for Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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