| NCT ID | NCT05667194 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Honghe Biotechnology Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-12-26 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2022-12-26 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.
Eligibility Criteria
Inclusion Criteria: * 1.Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 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 1. Advanced Solid Tumors 1. Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors for which there is no further standard treatment or for which the patient is not tolerated. 2. Patient has at least one measurable or evaluable target lesion by RECIST 1.1. 3. Patient has an ECOG status of 0 to 2. 2. Brain Metastases 1. Patient has at least one measurable or evaluable target lesion by RANO-BM. 3. rGBM 1. Patient with histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma has unequivocal evidence of GBM recurrence/progression following completion of standard treatment. 2. Patient has at measurable or evaluable target lesion by RANO. 3. 4.Patient has a Karnofsky Performance score (KPS) ≥60. Exclusion Criteria: * 1.Patient has received extensive radiation therapy. 2.Patients has the following infectious diseases: 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. 4\. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not limited to schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, or organic psychosis. 6\. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days. 9\. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has any other conditions that render them inappropriate for inclusion in the investigator's opinion.
Contact & Investigator
Wenbin Li
PRINCIPAL INVESTIGATOR
Beijing Titan Hospital,Capital Medical University
Frequently Asked Questions
Who can join the NCT05667194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05667194 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05667194 currently recruiting?
Yes, NCT05667194 is actively recruiting participants. Contact the research team at zhaomanqian@cnkh.com for enrollment information.
Where is the NCT05667194 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05667194 clinical trial?
NCT05667194 is sponsored by Sichuan Honghe Biotechnology Co., Ltd.. The principal investigator is Wenbin Li at Beijing Titan Hospital,Capital Medical University. The trial plans to enroll 45 participants.