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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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04250155
Collaborator
(none)
250
Enrollment
8
Locations
4
Arms
50.8
Anticipated Duration (Months)
31.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 9, 2020
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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 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

    		•
    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 Names:
  • RO5541267

    • Drug: XmAb24306
    Participants will receive IV XmAb24306 followed by IV atezolizumab.
    Other Names:
  • 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 Names:
  • RO5541267

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Adverse Events [Up to approximately 4 years]

    Secondary Outcome Measures

    1. Serum Concentration of XmAb24306 [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 [Up to approximately 4 years]

    3. Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 [Up to approximately 4 years]

    4. Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 [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) [Up to approximately 4 years]

    6. DOR as Based on Radiographic Assessment by the Investigator Using iRECIST [Up to approximately 4 years]

    7. PFS as Based on Radiographic Assessment by the Investigator Using iRECIST [Up to approximately 4 years]

    8. Overall Survival (OS) [Up to approximately 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Honor Health Research Institute Scottsdale Arizona United States 85258
    2 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    3 Yale University New Haven Connecticut United States 06511
    4 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    5 Peter Mac Callum Cancer Center East Melbourne Victoria Australia 3002
    6 Princess Margaret Hospital; Clinical Trials Pharmacy Toronto Ontario Canada M5G 2M9
    7 Asan Medical Center - PPDS Seoul Korea, Republic of 05505
    8 Universitair Medisch Centrum Groningen Groningen Netherlands 9713 GZ

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT04250155
    Other Study ID Numbers:
    • GO41596
    First Posted:
    Jan 31, 2020
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Atezolizumab

    Study Results

    No Results Posted as of Aug 5, 2022