An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Antibodies, Monoclonal; Atezolizumab

Criteria

Key General Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy >/= 12 weeks

• Adequate hematologic and end-organ function

• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen

• Negative serum pregnancy test for women of childbearing potential

• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

• Availability of representative tumor specimens

Key General 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 for HIV infection

• Prior allogeneic stem cell or solid organ transplantation