Changeflow GovPing Pharma & Drug Safety HER2 trial, trastuzumab serplulimab, biliary ur...
Routine Notice Added Final

HER2 trial, trastuzumab serplulimab, biliary urothelial cancer

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Summary

National Cancer Institute registered a Phase 2 clinical trial (NCT07506057) on ClinicalTrials.gov evaluating trastuzumab combined with serplulimab for HER2-positive biliary urothelial cancer. The study is sponsored by National Cancer Institute investigators and will assess safety and efficacy of this novel combination therapy in approximately 40 patients.

What changed

The National Cancer Institute registered a clinical trial (NCT07506057) on ClinicalTrials.gov testing trastuzumab combined with serplulimab in patients with HER2-positive biliary urothelial cancer. The trial is a Phase 2 study expected to enroll approximately 40 participants at NCI-affiliated clinical sites, with primary endpoints related to objective response rate and safety profile.

Healthcare institutions and clinical investigators at participating sites should review eligibility criteria for potential patient referrals. Trial sponsors must maintain accurate and complete registration information in compliance with FDAAA 801 requirements. Patients meeting inclusion criteria may be eligible for enrollment through participating oncology centers.

Archived snapshot

Apr 2, 2026

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Classification

Agency
NLM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07506057

Who this affects

Applies to
Clinical investigators Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing 6211 Healthcare Providers 3254.1 Biotechnology
Activity scope
Clinical Trial Reporting
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Consumer Protection

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