Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
GO41596
- NCT ID:
NCT04250155
Conditions
Interventions
Drug | Synonyms | Arms |
---|
XmAb24306 | RO7310729 | Phase 1a Dose Escalation |
Atezolizumab | RO5541267 | Phase 1b Dose Escalation |
XmAb24306 | RO7310729 | Phase 1b Dose Escalation |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1a Dose Escalation | Experimental | Participants will receive XmAb24306 until study treatment discontinuation or study termination. | |
Phase 1a Dose Expansion | Experimental | Participants will receive XmAb24306 until study treatment discontinuation or study termination. | |
Phase 1b Dose Escalation | Experimental | Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. | |
Phase 1b Dose Expansion | Experimental | Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of Participants with Adverse Events |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Serum Concentration of XmAb24306 |
Time Frame: | Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | DOR as Based on Radiographic Assessment by the Investigator Using iRECIST |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | PFS as Based on Radiographic Assessment by the Investigator Using iRECIST |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genentech, Inc. |
Last Updated
August 5, 2021