Phase I of XKH002 Injection in Patients

NCT06196762 | Recruiting Phase 1 FDA Drug

• 1 other identifier: XKH002-101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE)

  To determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE) of XKH002 in patients with advanced solid tumors

  24months

• safety and tolerability

  Incidence of treatment emergent adverse events (TEAEs), abnormal clinical laboratory tests, vital signs, electrocardiogram (ECG), and physical examination

  24months

Secondary Outcomes (12)

• pharmacokinetic (PK) parameters1

  24months

• pharmacokinetic (PK) parameters2

  24months

• pharmacokinetic (PK) parameters3

  24months

• pharmacokinetic (PK) parameters4

  24months

• pharmacokinetic (PK) parameters5

  24months

Study Arms (1)

XKH002

EXPERIMENTAL

A total of 5 dose cohorts will be enrolled and treated: 0.3, 1.0, 3.0, 10, and 20 mg/kg. The dose-escalation process will utilize both the accelerated titration and the conventional 3+3 methods.

Drug: XKH002 Injection

Interventions

XKH002 Injection DRUG

240 mg/4 mL/vial（60 mg/mL）

Also known as: XKH002

XKH002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older;
• Life expectancy at least 3 months.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor. Patient has had disease progression on one or more standard treatment regimens, or could not tolerate the treatment, or has no available treatment options.
• The physical status score of "Eastern Cancer Collaboration Group (ECOG)" (see Appendix 5) was 0-1;
• According to RECIST v1.1, all patients must have at least one evaluable lesion at baseline.
• For patients with stable BMS, all of the following criteria must be met:
• At least 28 days after receiving specialist treatment for central nervous system disorders and at least 14 days after the last corticosteroid treatment.
• Clinical symptoms were stable after the last treatment: no new central nervous system metastases or radiotherapy complications.
• Note: Patients who developed new progressive clinical symptoms or spinal cord compression or pIA disease after the last treatment were excluded.
• Laboratory test results during the screening period meet all of the following criteria:
• White blood cell count (WBC) ≥3.0×10\^9/L;
• Neutrophil count (ANC) ≥1.5×10\^9/L;
• Hemoglobin ≥90 g/L, assessed not having received blood transfusion within 7 days, and not dependent on erythropoietin (EPO);
• Platelets ≥90×10\^9/L;
• Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT), and International standardized ratio (INR) are all \<1.5×ULN;

You may not qualify if:

• The presence or history of any of the following:
• Current or past autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions (see Appendix 4) :
• Patients with autoimmune related hypothyroidism who only need thyroid hormone replacement therapy are eligible to participate in the study;
• Patients with type 1 diabetes who receive insulin therapy for stable control are eligible to participate in the study;
• Patients with only dermatologic clinical manifestations of eczema, psoriasis, chronic lichen simple or vitiligo (e.g., excluding psoriatic arthritis) are eligible to participate in the study if they meet all of the following criteria:
• \- The skin rash area must be \< 10% of the body surface area;
• Good disease control at baseline, requiring only inefficient local glucocorticoid therapy;
• There has been no acute exacerbation of the pre-existing condition requiring psoralen plus A-band ultraviolet radiation, methotrexate, retinoic acid, biologics, oral calcineurin inhibitors, or highly effective or oral glucocorticoid therapy in the past 12 months.
• Known allergy to any component of XKH002;
• Subjects who had major surgery or were scheduled for surgery for any reason within the 4 weeks prior to screening or who the investigator felt might need surgery.
• Radiotherapy (except palliative radiotherapy), chemotherapy, targeted therapy, endocrine therapy and other anti-tumor therapy, or other clinical trial drugs should be administered within 4 weeks before the first dose to the end of the trial; a) Patients receiving oral fluorouracil or small molecule targeted drugs were discontinued for ≤2 weeks or 5 half-lives (whichever is longer) before the first administration of the drug in this study; b) Study patients who were treated with mitomycin C or nitrosourea within 6 weeks prior to first administration of the drug; c) Chinese medicines with anti-tumor indications should be used within 2 weeks before the first use of the investigational drug.
• \. Previous antibody/drug therapy targeting B7-H4 immune checkpoint;
• Pregnant or lactating women;
• Patients who have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• Patients receiving erythropoietin (EPO) or thrombopoietin (TPO) within 2 weeks before the first dose, or colony stimulating factor (CSF) within 1 week before the first dose;

Sponsors & Collaborators

• Zhejiang Kanova Biopharmaceutical Co., LTD: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

RECRUITING

Study Officials

• Lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo You, MHA

CONTACT

010-82176552; jianguo.you@kanovabiopharma.com

Lin Shen, MD

CONTACT

010-88196561; doctorshenlin@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 0.3mg/kg, 1.0mg/kg, 3.0mg/kg,10mg/kg，20mg/kg.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: January 9, 2024
• Study Start: November 27, 2023
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)