A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of anti-HER3 monoclonal antibody GSK2849330 in subjects with advanced HER3-positive solid tumors

Phase 2

Completed

• Conditions: gastric/gastroesophageal cancer; head and neck cancer; or NSCLC; stage III-IV melanoma; 10027655

• Registration Number: NL-OMON44080
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

• Written informed consent obtained.
• Males and females >=18 years of age.
• ECOG status 0 or 1.
• Sufficient archival tumor specimen is available for HER3 (± NRG1) analysis or willingness to provide fresh tumor sample.
• Previously treated, unresectable stage III-IV melanoma, gastric/gastroesophageal cancer, head and neck cancer, or non small cell lung cancer, who are HER3 positive or (HN cancer or NSCLC) HER3 and NRG1 positive, see protocol page 23-25 for details.
• Adequate contraception for females of childbearing potential (see protocol page 22-23 for details).
• Men with a female partner of childbearing potential must agree to use effective contraception (see protocol page 23 for details).

Exclusion Criteria

• Untreated brain or meningeal metastases or spinal cord compression (see protocol page 25 for details).
• Prior HER3- directed treatment.
• Use of a prohibited medication (see protocol section 10.2).
• Evidence of significant cardiovascular risk (see protocol page 26 for details).
• Pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Drug plasma concentration, antibodies against GSK2849330, response evaluation<br /><br>(RESIST 1.1).</p><br>