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

May 22, 2026 updated by: Genentech, Inc.

A Phase Ia/Ib, 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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Parkville Cancer Clinical Trial Unit (PCCTU)
  • Belgium
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • GasthuisZusters Antwerpen
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Hospital de Clinicas de Porto Alegre HCPA PPDS
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Lombardy, Italy, 20141
        • Istituto Europeo di Oncologia
      • Rozzano, Lombardy, Italy, 20089
        • Istituto Clinico Humanitas
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System - PPDS
      • Seoul, South Korea, 05505
        • Asan Medical Center - PPDS
      • Seoul, South Korea, 06351
        • Samsung Medical Center - PPDS
  • Spain
      • Madrid, Spain, 28040
        • START Madrid-FJD, Hospital Fundacion Jimenez Diaz
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra-Madrid
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria de Navarra
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health Research Institute
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Health Centre - Palo Alto
      • San Francisco, California, United States, 94158-2545
        • University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • City of Hope Comprehensive Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1a Dose Escalation
Participants will receive XmAb24306 until study treatment discontinuation or study termination.
Drug: XmAb24306
Participants will receive intravenous (IV) XmAb24306.
Other Names:
  • RO7310729
Drug: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Other Names:
  • RO7310729
Experimental: Phase 1a Dose Expansion
Participants will receive XmAb24306 until study treatment discontinuation or study termination.
Drug: XmAb24306
Participants will receive intravenous (IV) XmAb24306.
Other Names:
  • RO7310729
Drug: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Other Names:
  • RO7310729
Experimental: Phase 1b Dose Escalation
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Drug: XmAb24306
Participants will receive intravenous (IV) XmAb24306.
Other Names:
  • RO7310729
Drug: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Other Names:
  • RO7310729
Drug: Atezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab
Other Names:
  • RO5541267
Experimental: Phase 1b Dose Expansion
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Drug: XmAb24306
Participants will receive intravenous (IV) XmAb24306.
Other Names:
  • RO7310729
Drug: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Other Names:
  • RO7310729
Drug: Atezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab
Other Names:
  • RO5541267

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Concentration of XmAb24306
Time Frame: Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment
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
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1
Time Frame: Up to approximately 4 years
Up to approximately 4 years
ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
DOR as Based on Radiographic Assessment by the Investigator Using iRECIST
Time Frame: Up to approximately 4 years
Up to approximately 4 years
PFS as Based on Radiographic Assessment by the Investigator Using iRECIST
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Overall Survival (OS)
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO41596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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