A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

NCT03752398 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: XmAb23104-01DUET-3
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 18

Brief Summary

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.

Conditions

Melanoma (Excluding Uveal Melanoma); Cervical Carcinoma; Pancreatic Carcinoma; Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative; Hepatocellular Carcinoma; Urothelial Carcinoma; Squamous Cell Carcinoma of the Head and Neck; Nasopharyngeal Carcinoma; Renal Cell Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Non-small Cell Lung Carcinoma; Small Cell Lung Cancer; Gastric or Gastroesophageal Junction Adenocarcinoma; Advanced Solid Tumors; Undifferentiated Pleomorphic Sarcoma

Keywords

DUET-3; Advanced solid tumors; Melanoma; Cervical Cancer; Pancreatic Cancer; Triple Negative Breast Cancer; Hepatocellular/Liver Cancer; Urothelial Cancer; Bladder Cancer; Renal Cell Cancer; Head and Neck Cancer; Colorectal Cancer; Endometrial Cancer; Non-small Cell Lung Cancer; Small Cell Lung Cancer; Gastric Cancer; Gastroesophageal Junction Cancer; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Treatment-related adverse events as assessed by CTCAE v4.03

  Safety and tolerability

  56 Days

Study Arms (2)

XmAb®23104 Monotherapy

EXPERIMENTAL

XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles

Biological: XmAb®23104

XmAb®23104 Combination Therapy with Ipilimumab

EXPERIMENTAL

XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)

Biological: XmAb®23104; Biological: Yervoy® (ipilimumab)

Interventions

XmAb®23104 BIOLOGICAL

Monoclonal bispecific antibody

XmAb®23104 Combination Therapy with Ipilimumab; XmAb®23104 Monotherapy

Yervoy® (ipilimumab) BIOLOGICAL

Monoclonal antibody

XmAb®23104 Combination Therapy with Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
• Histologically or cytologically confirmed advanced solid tumors, including the following:
• Melanoma (excluding uveal melanoma)
• Cervical carcinoma
• Pancreatic carcinoma
• Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
• Hepatocellular carcinoma
• Urothelial carcinoma
• Squamous cell carcinoma of the head and neck
• Nasopharyngeal carcinoma
• Renal cell carcinoma
• Colorectal carcinoma
• Endometrial carcinoma
• NSCLC
• Small cell lung cancer

You may not qualify if:

• Currently receiving other anticancer therapies
• Prior treatment with an investigational anti-ICOS therapy
• Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
• Treatment with nivolumab within 4 weeks of the start of study drug
• Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
• Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
• A life-threatening (Grade 4) irAE related to prior immunotherapy
• Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for endocrinopathies that are on stable hormone replacement doses
• Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
• Known active central nervous system involvement by malignant disease. Subjects with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging and are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• Active known or suspected autoimmune disease
• Receipt of an organ allograft
• History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
• Treatment with antibiotics within 14 days prior to first dose of study drug
• Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted).

Sponsors & Collaborators

• Xencor, Inc.: lead
• ICON plc: collaborator

Study Sites (18)

UC San Diego Moores Cancer Center

San Diego, California, 92093, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Mary Crowley Cancer Research - Medical City

Dallas, Texas, 75230, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, 22903, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Melanoma; Uterine Cervical Neoplasms; Pancreatic Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Carcinoma, Renal Cell; Colorectal Neoplasms; Endometrial Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Histiocytoma, Malignant Fibrous; Triple Negative Breast Neoplasms; Liver Neoplasms; Urinary Bladder Neoplasms; Head and Neck Neoplasms; Stomach Neoplasms; Sarcoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Diseases; Carcinoma, Squamous Cell; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Breast Neoplasms; Breast Diseases; Urinary Bladder Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chet Bohac, MD, MSc

  Xencor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: May 1, 2019
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)