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.

NCT05320874 Phase 1 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Xuanzhu Biopharmaceutical Co., Ltd.
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	232
Start date	2022-04
Completion	2026-11

Conditions

• Advanced Solid Tumor

Interventions

• KM257 Bispecific antibody

Primary outcomes

• Maximum tolerated dose (MTD) (Part 1a) — Up to 3 weeks
  Determine maximum tolerated dose (MTD) of KM257.
• Recommended phase 2 dose (RP2D) (if has) (Part 1a) — Up to 3 weeks
  Determine recommended phase 2 dose (RP2D) of KM257.
• Number of patients with adverse events.(Part 1a) — Up to 8 months.
  Number of patients who experienced an adverse event
• Objective response rate (ORR) (Part 1b) — Up to 2-3 years.
  Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment evaluated by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Countries

China