Clinical Trial: NCT04250155 - My Cancer Genome

NCT04250155

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.

Related Conditions:

Malignant Solid Tumor

Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04250155

Trial Eligibility

Document

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

Solid Tumors

Interventions

Drug	Synonyms	Arms
XmAb24306	RO7310729	Phase 1a Dose Escalation
Atezolizumab	RO5541267	Phase 1b Dose Escalation
XmAb24306	RO7310729	Phase 1b Dose Escalation

Purpose

Trial Arms

Name	Type	Description	Interventions
Phase 1a Dose Escalation	Experimental	Participants will receive XmAb24306 until study treatment discontinuation or study termination.	XmAb24306
Phase 1a Dose Expansion	Experimental	Participants will receive XmAb24306 until study treatment discontinuation or study termination.	XmAb24306
Phase 1b Dose Escalation	Experimental	Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.	Atezolizumab XmAb24306
Phase 1b Dose Expansion	Experimental	Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.	Atezolizumab XmAb24306

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

Clinical Trials /

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