Actively Recruiting
Phase 1 Trial of KH617
Led by Sichuan Honghe Biotechnology Co., Ltd. · Updated on 2024-11-27
45
Participants Needed
1
Research Sites
448 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.
CONDITIONS
Official Title
Phase 1 Trial of KH617
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent according to ICH-GCP and local laws before joining the trial
- Male or female aged 18 years or older
- Hemoglobin level of at least 9 g/dL
- Platelet count of at least 100 x 10^9/L
- Absolute neutrophil count of at least 1.5 x 10^9/L
- Albumin level of at least 3.0 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times the upper limit of normal
- Adequate kidney function with serum creatinine clearance over 50 mL/min and urine protein less than 2+, or urine protein over 2+ but 24-hour proteinuria less than 1 g
- Prothrombin time, INR, and aPTT less than or equal to 1.5 times the upper limit of normal (except for those on anticoagulants)
- Fully recovered from previous cancer treatment side effects to grade 1 or less
- Life expectancy of at least 3 months
- Diagnosed with unresectable, locally advanced, or metastatic malignant solid tumors without further standard treatment options or intolerance to such treatments
- At least one measurable or evaluable target lesion by RECIST 1.1
- ECOG status between 0 and 2
- For brain metastases, at least one measurable or evaluable lesion by RANO-BM
- For recurrent glioblastoma, confirmed evidence of tumor recurrence or progression after standard treatment
- Measurable or evaluable lesion by RANO for recurrent glioblastoma
- Karnofsky Performance Score of at least 60 for recurrent glioblastoma
You will not qualify if you...
- Prior extensive radiation therapy
- Active infectious diseases including active hepatitis B or C, positive hepatitis B surface antigen with active HBV DNA, positive HIV or AIDS
- Uncontrolled active infections
- Positive pregnancy test within 7 days before first dose for women of childbearing potential
- Unwillingness to use adequate contraception during and for 6 months after study treatment for men and women of childbearing potential
- Currently pregnant or breastfeeding
- History or current diagnosis of serious psychiatric disorders including schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral disorders, postpartum mental disorder, paranoid mental disorder, or organic psychosis
- Another malignancy within the past 5 years
- Active heart or cerebrovascular disease
- Participation in another investigational drug or device study within 28 days
- Severe allergic reaction to KH617
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Titan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Zhao Manxi
CONTACT
Z
Ziyun Gan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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