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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 : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE January 29, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE March 9, 2020
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Serum Concentration of XmAb24306 [ Time Frame: 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 ]
  • Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 [ Time Frame: 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 ]
  • 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 ]
  • DOR as Based on Radiographic Assessment by the Investigator Using iRECIST [ Time Frame: Up to approximately 4 years ]
  • PFS as Based on Radiographic Assessment by the Investigator Using iRECIST [ Time Frame: Up to approximately 4 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: XmAb24306
    Participants will receive intravenous (IV) XmAb24306.
    Other Name: RO7310729
  • 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
Study Arms  ICMJE
  • Experimental: Phase 1a Dose Escalation
    Participants will receive XmAb24306 until study treatment discontinuation or study termination.
    Intervention: Drug: XmAb24306
  • Experimental: Phase 1a Dose Expansion
    Participants will receive XmAb24306 until study treatment discontinuation or study termination.
    Intervention: Drug: XmAb24306
  • Experimental: Phase 1b Dose Escalation
    Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
    Interventions:
    • Drug: Atezolizumab
    • Drug: XmAb24306
  • Experimental: Phase 1b Dose Expansion
    Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
    Interventions:
    • Drug: Atezolizumab
    • Drug: XmAb24306
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO41596 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Italy,   Korea, Republic of,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250155
Other Study ID Numbers  ICMJE GO41596
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). 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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP