NCT05091528

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Silverback Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.

Conditions

• HER2-positive Breast Cancer
• HER2-positive Gastric Cancer
• HER2-positive Colorectal Cancer
• HER2-expressing Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SBT6050	Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
DRUG	trastuzumab deruxtecan	5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
DRUG	tucatinib	300 mg by mouth (PO) twice daily (BID)
DRUG	trastuzumab	8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
DRUG	capecitabine	1000 mg/m2 PO BID for 14 days of each 21-day cycle
DRUG	trastuzumab deruxtecan	6.4 mg/kg by IV infusion in 21-day cycles

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2021-10-25
• Last updated: 2022-08-18
• Results posted: 2022-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study