A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)

Phase 2

• Conditions: NUT Midline Carcinoma and other solid tumors; 10027655

• Registration Number: NL-OMON43804
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Males and females, 16 years and above (NL: 18 years and above).
• Diagnosis:
NUT Midline Carcinoma as diagnosed by the Central Laboratory. Subjects may be treatmentnaïve or have had prior therapy.
SCLC, CRPC, TNBC and ER+BC
• Subjects with solid tumors, with the exception of CRPC, must demonstrate measurable disease (NMC: see protocol page 50 for details).
• ECOG Performance Status 0-2 (NMC), 0-1 (other tumor types).
• Females of childbearing potential and males: adequate method of contraception.
• CRPC subjects:
Histologically or cytologically confirmed prostate adenocarcinoma, surgically castrated or continuously medically castrated (for *8 weeks)
Persistent disease with evidence of disease progression following standard therapy(ies). See protocol page 52 for details.
Serum testosterone level <1.7 nmol/l.
PSA level >=2.0 ng/mL.

Exclusion Criteria

• Prior and current treatments: see protocol page 53 for details.
• Evidence of severe or uncontrolled systemic diseases. See protocol page 53 for details.
• Cardiac and or ECG abnormalities. See protocol page 54 for details.
• GSK525762 is a benzodiazepine class molecule. Any serious known immediate or delayed hypersensitivity reaction(s) to GSK525762 or idiosyncrasy to drugs chemically related to the investigational drug.
• Hemoptysis > 1 teaspoon in 24 hours within the last 28 days.
• History of major gastrointestinal bleeding within the last 6 months. Any evidence of active gastrointestinal bleeding.
• Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events. Overall response rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PK parameters, cardiac safety parameters, progression free survival, time to<br /><br>and duration of response, overall survival.</p><br>