Phase 1 Trial of KH617

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: KH617

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ting Hu; Phone Number: 86 13880999215; Email: huting@cnkh.com
• Study Contact Backup: Name: Zhao Manxi; Phone Number: 86 15882459305; Email: zhaomanqian@cnkh.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Titan Hospital,Capital Medical University
      • Contact: Wenbin Li, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KH617 dose 1; Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle	Drug: KH617; KH617 is s freeze-dried powder injection
Experimental: KH617 dose 2; Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle	Drug: KH617; KH617 is s freeze-dried powder injection
Experimental: KH617 dose 3; Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle	Drug: KH617; KH617 is s freeze-dried powder injection
Experimental: KH617 dose 4; Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle	Drug: KH617; KH617 is s freeze-dried powder injection
Experimental: KH617 dose 5; Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle	Drug: KH617; KH617 is s freeze-dried powder injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MTD	90 weeks
DLT	90 weeks
RP2D	154 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
ORR	154 weeks
PFS	154 weeks

Collaborators and Investigators

• Sponsor: Sichuan Honghe Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Wenbin Li, Beijing Titan Hospital,Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2022
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KH617

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No