Phase 1 Trial of KH617

NCT ID: NCT05667194

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-26
• Study Completion Date: 2031-08-31

Brief Summary

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

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KH617 dose 1

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Group Type: EXPERIMENTAL

KH617

Intervention Type: DRUG

KH617 is s freeze-dried powder injection

KH617 dose 2

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Group Type: EXPERIMENTAL

KH617

Intervention Type: DRUG

KH617 is s freeze-dried powder injection

KH617 dose 3

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Group Type: EXPERIMENTAL

KH617

Intervention Type: DRUG

KH617 is s freeze-dried powder injection

KH617 dose 4

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Group Type: EXPERIMENTAL

KH617

Intervention Type: DRUG

KH617 is s freeze-dried powder injection

KH617 dose 5

Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle

Group Type: EXPERIMENTAL

KH617

Intervention Type: DRUG

KH617 is s freeze-dried powder injection

Interventions

KH617

KH617 is s freeze-dried powder injection

Intervention Type: DRUG

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Honghe Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenbin Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Titan Hospital,Capital Medical University

Locations

Beijing Titan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhao Manxi

Role: CONTACT

zhaomanqian@cnkh.com

86 15882459305

Ziyun Gan

Role: CONTACT

020735@cnkh.com

86 15520826510

Facility Contacts

Wenbin Li, M.D.

Role: primary

Other Identifiers

KH617

Identifier Type: -

Identifier Source: org_study_id