NCT05320874

A Study of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors.

The Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors in a Single-arm, Open-label, Multi-center Phase 1 Clinical Study.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, 2-part study to investigate the safety, tolerability, pharmacokinetics and efficacy of KM257 by itself and combined with selected chemotherapy agents in patients with advanced HER2-positive or expressing cancers.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	KM257 Bispecific antibody	Part 1a dose escalation: There will be 3 increasing dose levels (3mg/kg,6mg/kg,12mg/kg). Patients will be intravenously administrated with one dose of KM257, QW for continuous cycles of 21 consecutive days for each cycle. The dosing interval may be adjusted during the study based on emerging data from this trial. Part 1b dose expansion: Part1b:For cohort 1 and cohort2, KM257 will be given at the RP2D identified in Part1a; For cohort 3 to 7:KM257 will be given combined with one of the following selected drug combination: Drug: Capecitabine Combination therapy with KM257 - Cohort 3 Drug: Paclitaxel or Docetaxel or Irinotecan Combination therapy with KM257 - Cohort 4 Drug: Gemcitabine+Cisplatin Combination therapy with KM257 - Cohort 5 Drug: Gemcitabine+Cisplatin or Carboplatin Combination therapy with KM257 - Cohort 6 Drug:Carboplatin+Paclitaxel Combination therapy with KM257 - Cohort 7

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-06-01
• Completion: 2026-11-01
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: China