Phase 1 Trial of KH617

Last updated: November 26, 2024
Sponsor: Sichuan Honghe Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

KH617

Clinical Study ID

NCT05667194
KH617
  • Ages > 18
  • All Genders

Study Summary

KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Signed and dated written informed consent in accordance with International Councilfor Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial.

2.Patient is male or female ≥18 years of age. 3.Patient must satisfy the followinglaboratory test results: a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10^9/L c.Absolute neutrophilcount≥1.5×10^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartateaminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function,defined as estimated serum creatinine clearance>50mL/minute calculated using theCockcroft-Gault equation,urine protein<2+ or urine protein>2+ but 24-hourproteinuria<1g h.Prothrombin time, international normalized ratio, and activatedpartial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulanttherapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0)from all previous acute treatment-related toxic effects of previous cancertreatments prior to enrollment.

5.Life expectancy at least 3 months. 6.Specific Inclusion Criteria

  1. Advanced Solid Tumors

  2. Patients with histopathology and/or cytology diagnosed as unresectable,locally advanced or metastatic malignant solid tumors for which there isno further standard treatment or for which the patient is not tolerated.

  3. Patient has at least one measurable or evaluable target lesion by RECIST 1.1.

  4. Patient has an ECOG status of 0 to 2.

  5. Brain Metastases

  6. Patient has at least one measurable or evaluable target lesion by RANO-BM.

  7. rGBM

  8. Patient with histopathology and/or cytology diagnosed advanced malignantadult diffuse glioma has unequivocal evidence of GBMrecurrence/progression following completion of standard treatment.

  9. Patient has at measurable or evaluable target lesion by RANO.

  10. 4.Patient has a Karnofsky Performance score (KPS) ≥60.

Exclusion

Exclusion Criteria:

  • 1.Patient has received extensive radiation therapy. 2.Patients has the followinginfectious diseases: a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis Bb.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolledactive infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 daysbefore the first administration (only for female with bearing potential ), or maleand female with bearing potential who are unwilling to use adequate contraceptionfor the duration of the study, and for a minimum of6 months after last dose ofKH617.
  1. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previousphrenoblabia history or currently phrenoblabia Including but not limited toschizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia,Alzheimer's disease, behavioral volitional disorder, postpartum mentaldisorder, paranoid mental disorder, or organic psychosis.

  2. Patient has had another malignancy within the previous 5 years. 7. Patient hasactive cardiac or cerebrovascular disease. 8.Patient has participated inanother investigational study using an investigational or marketed drug ordevice within 28 days.

  3. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has anyother conditions that render them inappropriate for inclusion in theinvestigator's opinion.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: KH617
Phase: 1
Study Start date:
December 26, 2022
Estimated Completion Date:
August 31, 2031

Connect with a study center

  • Beijing Titan Hospital,Capital Medical University

    Beijing, Beijing 100000
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.