NCT04257110

A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors

A First-in-human, Open Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 consists of expansion cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, for exploring 1 or more RP2Ds or schedules for expanding/deepening the information/knowledge about clinical safety, clinical pharmacokinetics and anti-tumor activity.

Detailed description

This is an open-label, FIH, phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced /metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 of this study will follow accelerated titration and traditional "3 + 3" design. Part 2 is a cohort expansion study with HER2 expressing locally advanced/metastatic solid tumors. Part 2 consists of 4 cohorts: Cohort 1: Patients with HER2 overexpressing or positive (defined as IHC 3+ or IHC 2+/FISH positive) locally advanced or metastatic breast cancer who have progressed on prior standard therapies including anti HER2 therapy Cohort 2: Patients with HER2 low expressing (defined as IHC 2+ /FISH negative, or IHC 1+) locally advanced or metastatic breast cancer who have progressed on prior standard therapies. Cohort 3: Patients with HER2 overexpressing or positive (defined as IHC 3+ or IHC 2+/FISH positive) locally advanced or metastatic gastric cancer or gastroesophageal junction cancer who have progressed on prior standard therapies. Cohort 4: Patients with HER2 overexpressing or positive (defined as IHC 3+, or IHC 2+/FISH positive) locally advanced or metastatic solid tumors (other than breast cancer and gastric or gastroesophageal junction cancer) who have progressed on prior standard therapies. Patients with HER2 mutation or amplification by NGS can also be enrolled in this cohort.

Conditions

• Locally Advanced/Metastatic HER2 Positive Solid Tumors

Interventions

Type	Name	Description
DRUG	BB-1701	BB-1701 will be administered as an intravenous infusion, every 3 weeks or every 4 weeks or every 6 weeks.

Timeline

• Start date: 2020-07-28
• Primary completion: 2024-08-31
• Completion: 2024-12-31
• First posted: 2020-02-05
• Last updated: 2025-07-24

Locations

12 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study