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.

XKH002 Injection

Jianguo You, MHA

Lin Shen, MD

Lin Shen

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.

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).

0.3mg/kg, 1.0mg/kg, 3.0mg/kg,10mg/kg，20mg/kg.

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

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

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

PK parameters including steady-state volume of distribution (Vss)

PK parameters including area under the concentration-time (AUC)

PK parameters including peak plasma concentration (Cmax)

To evaluate the antitumor activity of XKH002.Objective response rate (ORR)

To evaluate the antitumor activity of XKH002.disease control rate (DCR)

To evaluate the antitumor activity of XKH002. duration of overall response (DOR)

To evaluate the antitumor activity of XKH002.and progression-free survival (PFS)

To evaluate the antitumor activity of XKH002.according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

To evaluate the immunogenicity of XKH002.Detection of antidrug antibodies (ADA)

Spots Global Cancer Trial Database for xkh002 injection