NCT06196762

Phase I of XKH002 Injection in Patients

A Phase 1, First-in-human (FIH),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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Overall Study Design: 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. The study will include 2 parts, dose escalation and dose expansion Part 1: Dose Escalation Based on the results of previous non-clinical efficacy and toxicology experiments and the prediction of human PK, the initial dose was set at 0.3 mg/kg, and the dose was increased according to 5 dose groups: The 0.3, 1.0, 3.0, 10,20 mg/kg dose-escalation phase will include accelerated titration and a traditional 3+3 dose-escalation design, with 16-30 participants expected to participate in the study. The MTD or MAD will be identified, and all the available PK, PD, tolerability and activity in addition to safety data will be evaluated to select the recommended dose for expansion (RDE). Part 2: Dose Expansion Based on the results of the dose-escalation trial (safety/tolerability, initial efficacy, PK/PD, etc.), it is expected that 20 to 80 participants will be enrolled in the study by RDE dose expansion of monotherapy for selected subjects of 1 to 4 tumor types. Number of Participants: Approximately 16 to 30 patients will be enrolled in Part 1 (dose escalation). Approximately 20 to 80 patients will be enrolled in Part 2 (dose expansion).

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	XKH002 Injection	240 mg/4 mL/vial（60 mg/mL）

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2024-01-09
• Last updated: 2024-10-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study