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
participants needed

250
sponsor

Genentech, Inc.

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Updated on 19 February 2024

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cancer

serum pregnancy test

measurable disease

atezolizumab

solid tumour

solid tumor

anticoagulants

solid neoplasm

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.

Details

Condition	Solid Tumors
Age	18-100 years
Treatment	Atezolizumab, XmAb24306
Clinical Study Identifier	NCT04250155
Sponsor	Genentech, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
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

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Study Definition

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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