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

• ClinicalTrials.gov Identifier: NCT04250155
• Recruitment Status: Recruiting
• First Posted: January 31, 2020
• Last Update Posted: June 2, 2023
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: January 29, 2020
• First Posted Date: January 31, 2020
• Last Update Posted Date: June 2, 2023
• Actual Study Start Date: March 9, 2020
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 29, 2020): Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 4 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 29, 2020): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2024
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Reference Study ID Number: GO41596 https://forpatients.roche.com/; 888-662-6728; global-roche-genentech-trials@gene.com

• Listed Location Countries: Australia, Canada, Korea, Republic of, Netherlands, United States
• Removed Location Countries: Belgium, Brazil, Italy, Spain

Administrative Information

• NCT Number: NCT04250155
• Other Study ID Numbers: 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

• 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).

• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Genentech, Inc.
• Verification Date: June 2023