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

NCT ID: NCT04250155

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2026-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1a Dose Escalation

Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Group Type EXPERIMENTAL

XmAb24306

Intervention Type DRUG

Participants will receive intravenous (IV) XmAb24306.

Phase 1a Dose Expansion

Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Group Type EXPERIMENTAL

XmAb24306

Intervention Type DRUG

Participants will receive intravenous (IV) XmAb24306.

Phase 1b Dose Escalation

Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

Participants will receive IV XmAb24306 followed by IV atezolizumab

XmAb24306

Intervention Type DRUG

Participants will receive IV XmAb24306 followed by IV atezolizumab.

Phase 1b Dose Expansion

Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

Participants will receive IV XmAb24306 followed by IV atezolizumab

XmAb24306

Intervention Type DRUG

Participants will receive IV XmAb24306 followed by IV atezolizumab.

Interventions

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XmAb24306

Participants will receive intravenous (IV) XmAb24306.

Intervention Type DRUG

Atezolizumab

Participants will receive IV XmAb24306 followed by IV atezolizumab

Intervention Type DRUG

XmAb24306

Participants will receive IV XmAb24306 followed by IV atezolizumab.

Intervention Type DRUG

Other Intervention Names

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RO7310729 RO5541267 RO7310729

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Honor Health Research Institute

Scottsdale, Arizona, United States

Site Status

Stanford Health Centre - Palo Alto

Palo Alto, California, United States

Site Status

University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

City of Hope Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status

Parkville Cancer Clinical Trial Unit (PCCTU)

Melbourne, Victoria, Australia

Site Status

GasthuisZusters Antwerpen

Wilrijk, Antwerp, Belgium

Site Status

Hospital de Clinicas de Porto Alegre HCPA PPDS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, , Brazil

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Site Status

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Site Status

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Site Status

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, Netherlands

Site Status

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System - PPDS

Seoul, , South Korea

Site Status

Asan Medical Center - PPDS

Seoul, , South Korea

Site Status

Samsung Medical Center - PPDS

Seoul, , South Korea

Site Status

C.H. Regional Reina Sofia - PPDS

Córdoba, Cordoba, Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Clinica Universidad de Navarra-Madrid

Madrid, , Spain

Site Status

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Countries

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United States Australia Belgium Brazil Canada Italy Netherlands South Korea Spain

Other Identifiers

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GO41596

Identifier Type: -

Identifier Source: org_study_id

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