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

NCT04250155 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: GO41596
• Study Type: interventional
• Target: 195
• Locations: 9 countries
• Sites: 25

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events

  Up to approximately 4 years

Secondary Outcomes (8)

• Serum Concentration of XmAb24306

  Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment

• Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to approximately 4 years

• Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1

  Up to approximately 4 years

• Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1

  Up to approximately 4 years

• ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)

  Up to approximately 4 years

Study Arms (4)

Phase 1a Dose Escalation

EXPERIMENTAL

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

Drug: XmAb24306

Phase 1a Dose Expansion

EXPERIMENTAL

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

Drug: XmAb24306

Phase 1b Dose Escalation

EXPERIMENTAL

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

Drug: Atezolizumab; Drug: XmAb24306

Phase 1b Dose Expansion

EXPERIMENTAL

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

Drug: Atezolizumab; Drug: XmAb24306

Interventions

XmAb24306 DRUG

Participants will receive intravenous (IV) XmAb24306.

Also known as: RO7310729

Phase 1a Dose Escalation; Phase 1a Dose Expansion

Atezolizumab DRUG

Participants will receive IV XmAb24306 followed by IV atezolizumab

Also known as: RO5541267

Phase 1b Dose Escalation; Phase 1b Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (25)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

Stanford Health Centre - Palo Alto

Palo Alto, California, 94304, United States

Location

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

San Francisco, California, 94158-2545, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

City of Hope Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Parkville Cancer Clinical Trial Unit (PCCTU)

Melbourne, Victoria, 3000, Australia

Location

GasthuisZusters Antwerpen

Wilrijk, Antwerp, 2610, Belgium

Location

Hospital de Clinicas de Porto Alegre HCPA PPDS

Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, 01246-000, Brazil

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System - PPDS

Seoul, 03722, South Korea

Location

Asan Medical Center - PPDS

Seoul, 05505, South Korea

Location

Samsung Medical Center - PPDS

Seoul, 06351, South Korea

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Clinica Universidad de Navarra-Madrid

Madrid, 28027, Spain

Location

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

atezolizumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: March 9, 2020
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (4); BE (1); BR (2); NL (2); CA (1); AU (1); KR (5); US (6); IT (3)