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Trial record 1 of 1 for:    NCT04250155
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250155
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: XmAb24306 Drug: Atezolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: RO7310729

Experimental: Phase 1b Dose Escalation
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Drug: Atezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab
Other Name: RO5541267

Drug: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Other Name: RO7310729

Experimental: Phase 1b Dose Expansion
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Drug: Atezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab
Other Name: RO5541267

Drug: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Other Name: RO7310729




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 4 years ]

Secondary Outcome Measures :
  1. Serum Concentration of XmAb24306 [ Time Frame: 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 [ Time Frame: Up to approximately 4 years ]
  3. Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 [ Time Frame: Up to approximately 4 years ]
  4. Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 [ Time Frame: 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) [ Time Frame: Up to approximately 4 years ]
  6. DOR as Based on Radiographic Assessment by the Investigator Using iRECIST [ Time Frame: Up to approximately 4 years ]
  7. PFS as Based on Radiographic Assessment by the Investigator Using iRECIST [ Time Frame: Up to approximately 4 years ]
  8. Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250155


Contacts
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Contact: Reference Study ID Number: GO41596 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06511
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Australia, Victoria
Peter Mac Callum Cancer Center Recruiting
East Melbourne, Victoria, Australia, 3002
Netherlands
Universitair Medisch Centrum Groningen Not yet recruiting
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04250155    
Other Study ID Numbers: GO41596
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).

Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Atezolizumab
Antineoplastic Agents