Testing KH617 for advanced solid tumors
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
This study is testing an injectable treatment called KH617 to see if it is safe and tolerable for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chengdu Kanghong Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05667194 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates KH617, an injectable treatment for patients with advanced solid tumors. Participants will receive KH617, which is prepared by diluting it with 5% Dextrose Injection. The trial aims to assess the safety and tolerability of this intervention in a Phase 1 setting. Eligible patients must meet specific laboratory criteria and provide informed consent before participation.
Who should consider this trial
Good fit: Ideal candidates for this trial are adults aged 18 and older with advanced solid tumors who meet the specified laboratory criteria.
Not a fit: Patients with severe comorbidities or those who do not meet the laboratory test requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this approach is in a Phase 1 setting, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Titan Hospital,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wenbin Li — Beijing Titan Hospital,Capital Medical University
- Study coordinator: Zhao Manxi
- Email: zhaomanqian@cnkh.com
- Phone: 86 15882459305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.