A Phase 1a/1b Open label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Recruiting

• Conditions: Locally Advanced or Metastatic Solid Tumors; locally advanced or tumors that metastasized; 10027655

• Registration Number: NL-OMON56429
• Lead Sponsor: Genentech Inc. (een lid van de Roche Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

• Age >= 18 years at time of signing Informed Consent Form
• ECOG Performance Status of 0 or 1
• Life expectancy >= 12 weeks
• Adequate hematologic and end-organ function
• For patients receiving therapeutic anticoagulation: stable anticoagulant
regimen
• Negative serum pregnancy test for women of childbearing potential: agreement
to remain abstinent (refrain from heterosexual intercourse) or use contraception
• For men: agreement to remain abstinent (refrain from heterosexual
intercourse) or use a condom
• Histologically confirmed locally advanced, recurrent, or metastatic incurable
solid tumor malignancy
• Measurable disease per RECIST v1.1

Exclusion Criteria

• Pregnant or breastfeeding, or intending to become pregnant during the study
• Significant cardiovascular disease
• Current treatment with medications that prolong the QT interval
• Known clinically significant liver disease
• Poorly controlled Type 2 diabetes mellitus
• Symptomatic, untreated, or actively progressing CNS metastases
• History of leptomeningeal disease
• History of malignancy other than disease under study within 3 years prior to
screening
• Active or history of autoimmune disease or immune deficiency
• Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein
Barr virus infection
• Positive test for HIV infection
• Prior allogeneic stem cell or solid organ transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Incidence and severity of adverse events, with severity determined according<br /><br>to National Cancer Institute Common Terminology Criteria for Adverse Events,<br /><br>Version 5.0 (NCI CTCAE v5.0)<br /><br>-Change from baseline in targeted vital signs<br /><br>-Change from baseline in targeted clinical laboratory test results<br /><br>-Change from baseline in ECGs parameters</p><br>