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

July 1, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Câncer do Estado de São 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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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