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Solid TumorsPhase 1NCT04250155

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

A Phase 1 study testing XmAb24306 and Atezolizumab in people with Solid Tumors, run by Genentech, Inc. at 25 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
XmAb24306 and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
25 sitesin 9 countries
Study dates
9 Mar 2020to 27 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

25 sites in 9 countries.

25 sites in 9 countries

United States6 sites

  • City of Hope Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06520

  • Stanford Health Centre - Palo Alto

    Palo Alto, California, 94304

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

    San Francisco, California, 94158-2545

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center - PPDS

    Seoul, 06351

Other trials in South Korea

Spain4 sites

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Italy3 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

Other trials in Italy

Brazil2 sites

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Rio Grande do Sul, 90560-030

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, 01246-000

Other trials in Brazil

Netherlands2 sites

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, North Holland, 1066 CX

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

Australia1 site

  • Parkville Cancer Clinical Trial Unit (PCCTU)

    Melbourne, Victoria, 3000

Other trials in Australia

Belgium1 site

  • GasthuisZusters Antwerpen

    Wilrijk, Antwerp, 2610

Other trials in Belgium

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Conditions
Solid Tumors
Being tested
XmAb24306, Atezolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XmAb24306Drug

    Also called RO7310729

    Participants will receive intravenous (IV) XmAb24306.

  • AtezolizumabDrug

    Also called RO5541267

    Participants will receive IV XmAb24306 followed by IV atezolizumab

  • XmAb24306Drug

    Also called RO7310729

    Participants will receive IV XmAb24306 followed by IV atezolizumab.

Study groups in NCT04250155
Study groupRoleWhat they receive
Phase 1a Dose EscalationExperimentalParticipants will receive XmAb24306 until study treatment discontinuation or study termination.
Receives: Drug: XmAb24306
Phase 1a Dose ExpansionExperimentalParticipants will receive XmAb24306 until study treatment discontinuation or study termination.
Receives: Drug: XmAb24306
Phase 1b Dose EscalationExperimentalParticipants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Receives: Drug: Atezolizumab; Drug: XmAb24306
Phase 1b Dose ExpansionExperimentalParticipants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Receives: Drug: Atezolizumab; Drug: XmAb24306

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events

    Measured: Up to approximately 4 years

Secondary outcomes (8)

  1. Serum Concentration of XmAb24306

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

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

    Measured: Up to approximately 4 years

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

    Measured: Up to approximately 4 years

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

    Measured: Up to approximately 4 years

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

    Measured: Up to approximately 4 years

  6. DOR as Based on Radiographic Assessment by the Investigator Using iRECIST

    Measured: Up to approximately 4 years

  7. PFS as Based on Radiographic Assessment by the Investigator Using iRECIST

    Measured: Up to approximately 4 years

  8. Overall Survival (OS)

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start9 Mar 2020
  3. Primary completion27 May 2026
  4. Study completion27 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04250155
Sponsor's protocol ID
GO41596
Status last verified
Jul 2026
First submitted
29 Jan 2020
Last updated
2 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XmAb24306 and Atezolizumab in people with Solid Tumors, run by Genentech, Inc. at 25 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, South Korea, Spain, Italy, Brazil and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04250155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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