NCT05804864

A Study of KM501 in Patients With Solid Tumors

A Single-arm, Open, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of the KM501 Double-antibody ADC in Subjects With Advanced Solid Tumors That Express, Amplify, or Mutate HER2

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, open, multicenter Phase I study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the KM501 double-antibody ADC in subjects with advanced solid tumors that express, amplify, or mutate HER2

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	KM501	1a: The program evaluated six dose levels, i.e., 0.1, 0.3, 0.6, 1.2, 1.8, 2.4 mg/kg, An accelerated titration was performed in the 0.1 and 0.3 mg/kg dose groups, and then a Bayesian optimal interval design was used to determine MTDS for four subsequent dose levels. Ib: The antitumor activity of KM501 monotherapy in subjects with specific types of tumors that are HER2-positive or express, amplify, or mutate will be evaluated at the RP2D dose level

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: China