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NCT Number: NCT04250155

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

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parkville Cancer Clinical Trial Unit (PCCTU), Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XmAb24306

Drug

Participants will receive intravenous (IV) XmAb24306.

Other names: RO7310729

Atezolizumab

Drug

Participants will receive IV XmAb24306 followed by IV atezolizumab

Other names: RO5541267

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Up to approximately 4 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2020
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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