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

Phase 1

Active, not recruiting

• Conditions: Solid Tumors
• Interventions: Drug: XmAb24306; Drug: Atezolizumab

• Registration Number: NCT04250155
• Lead Sponsor: Genentech, Inc.

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 available

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2020-03-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-09-14
• Study Completion: 2025-09-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1a Dose Escalation	XmAb24306	Participants will receive XmAb24306 until study treatment discontinuation or study termination.
Phase 1a Dose Expansion	XmAb24306	Participants will receive XmAb24306 until study treatment discontinuation or study termination.
Phase 1b Dose Escalation	Atezolizumab	Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Phase 1b Dose Escalation	XmAb24306	Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Phase 1b Dose Expansion	Atezolizumab	Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
Phase 1b Dose Expansion	XmAb24306	Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events	Up to approximately 4 years

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1	Up to approximately 4 years
Serum Concentration of XmAb24306	Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1	Up to approximately 4 years
Overall Survival (OS)	Up to approximately 4 years
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
ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)	Up to approximately 4 years
DOR as Based on Radiographic Assessment by the Investigator Using iRECIST	Up to approximately 4 years
PFS as Based on Radiographic Assessment by the Investigator Using iRECIST	Up to approximately 4 years

Trial Locations

Locations (30)

VU Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Clinica Universidad de Navarra-Madrid; 🇪🇸 Madrid, Spain

C.H. Regional Reina Sofia - PPDS; 🇪🇸 Cordoba, Spain

START Madrid-FJD, Hospital Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Samsung Medical Center - PPDS; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center - PPDS; 🇰🇷 Seoul, Korea, Republic of

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Honor Health Research Institute; 🇺🇸 Scottsdale, Arizona, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Stanford Health Centre - Palo Alto; 🇺🇸 Palo Alto, California, United States

UCSF Helen Diller Family CCC; 🇺🇸 San Francisco, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

The University of Oklahoma Health Sciences Center; Peggy and Charles Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

SCRI Oncology Partners; 🇺🇸 Nashville, Tennessee, United States

Virginia Cancer Specialists (Fairfax) - USOR; 🇺🇸 Fairfax, Virginia, United States

Peter Mac Callum Cancer Center; 🇦🇺 East Melbourne, Victoria, Australia

GasthuisZusters Antwerpen; 🇧🇪 Wilrijk, Belgium

Hospital de Clinicas de Porto Alegre HCPA PPDS; 🇧🇷 Porto Alegre, PA, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP; 🇧🇷 Sao Paulo, SP, Brazil

Princess Margaret Hospital; Clinical Trials Pharmacy; 🇨🇦 Toronto, Ontario, Canada

Sir Mortimer B Davis Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Istituto Nazionale Dei Tumori; Dipartimento Chirurgia Generale - Unita' Trapianti Fegato; 🇮🇹 Milano, Lombardia, Italy

Istituto Europeo Di Oncologia; 🇮🇹 Milano, Lombardia, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano (MI), Lombardia, Italy

Seoul National University Bundang Hospital; Pharmacy; 🇰🇷 Seongnam-si, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital Yonsei University Health System - PPDS; 🇰🇷 Seoul, Korea, Republic of