NCT03944499

Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.

A Phase I,Multicenter,Open-label,Single-arm Study:A Dose-escalation Phase Evaluating FS1502 in Patients With HER2 Expressed Advanced Solid Tumors,and a Dose-expanded Phase in Patients With Local Advanced or Metastatic,HER2+ Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study comprises two phases: Phase 1a and Phase 1b. The purpose of the study is to observe the safety， tolerability and efficacy of FS-1502.

Detailed description

The study is designed as an open label, single arm, Phase 1a/1b study with a dose-escalation phase to evaluate FS-1502 in patients with HER2 expressed advanced malignant solid tumors (phase 1a) and an expanded cohort (phase 1b) to evaluate FS-1502 in patients with metastatic, HER2-positive breast cancer. The primary aim of the phase 1a portion of this study is to determine the safety and tolerability of FS-1502. The primary aim of the phase 1b portion is to demonstrate efficacy.

Conditions

• Solid Tumor
• Breast Cancer

Interventions

Type	Name	Description
DRUG	FS-1502	Dose-Escalation Phase (Phase 1a)： FS-1502 dose-escalation will be proceeded on standard 3+3 design with starting dose of 0.1 mg/kg, IV, once per 28 days, 28 days as a cycle in the V1.2 and V2.0 regimens; IV, once per 21 days, 21 days as a cycle in the V3.0 regimens.. Dose level 1: 0.1 mg/kg; Dose level 2: 0.2 mg/kg; Dose level 3: 0.4 mg/kg; Dose level 4: 0.6 mg/kg; Dose level 5: 0.8 mg/kg; Dose level 6: 1.0 mg/kg; Dose level 7: 1.3 mg/kg. If 1.3mg/kg is still tolerated safely and in line with linear kinetic characteristics, and combined with the results of PK, PD, safety and effectiveness, a comprehensive assessment is made to determine whether to continue the dose escalating. The subsequent dose increase ratio is 33% (the dose increase ratio can be adjusted according to the previous data results) until MTD or RP2D. Dose-expansion Phase (Phase 1b) : RP2D determined in phase 1a, IV.

Timeline

• Start date: 2019-10-11
• Primary completion: 2024-05-20
• Completion: 2024-08-12
• First posted: 2019-05-09
• Last updated: 2025-09-15

Locations

12 sites across 1 country: China