NCT04501770

A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Profiles of the Recombinant Anti-HER2 and Anti-CD3 Humanized Bispecific Antibody (M802) in HER2-Positive Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Wuhan YZY Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D).

Conditions

• HER2-Positive Solid Tumors

Interventions

Type	Name	Description
DRUG	Chort 1 of M802	Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg.
DRUG	Chort 2 of M802	Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg.
DRUG	Cohort 3 of M802	Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg.
DRUG	Cohort 4 of M802	Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
DRUG	Cohort 5 of M802	Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
DRUG	Cohort 6 of M802	Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg.
DRUG	Cohort 7 of M802	Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg.
DRUG	Cohort 8 of M802	Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.

Timeline

• Start date: 2018-09-27
• Primary completion: 2022-05-06
• Completion: 2022-09-14
• First posted: 2020-08-06
• Last updated: 2025-07-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study