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New treatment option for Advanced Solid Tumors
Official title Phase 1 Trial of KH617
ClinicalTrials.gov ID: NCT05667194
What this study is testing
What is KH617?
KH617 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1.Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local...
- Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors for which there is no...
- Patient has at least one measurable or evaluable target lesion by RECIST 1.1.
- Patient has an ECOG status of 0 to 2.
- Brain Metastases
You likely can't join if
- 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...
- 4\. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not...
- 6\. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has...
- 9\. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has any other conditions that render them inappropriate for inclusion in...
See the full eligibility 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...
- 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.
- Patient has at least one measurable or evaluable target lesion by RECIST 1.1.
- Patient has an ECOG status of 0 to 2.
- Brain Metastases
- Patient has at least one measurable or evaluable target lesion by RANO-BM.
- rGBM
- Patient with histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma has unequivocal evidence of GBM recurrence/progression following completion of standard treatment.
- Patient has at measurable or evaluable target lesion by RANO.
- 4.Patient has a Karnofsky Performance score (KPS) ≥60.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.