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BRIEF TITLE: Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors

  • Org Study ID: XmAb23104-01
  • Secondary ID: DUET-3
  • NCT ID: NCT03752398
  • NCT Alias:
  • Sponsor: Xencor, Inc. - Industry
  • Source: Xencor, Inc.

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.

Overal Status Start Date Phase Study Type
Recruiting May 1, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Treatment-related adverse events as assessed by CTCAE v4.03

Primary Outcome 1 - Time Frame: 56 Days


  • 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


Inclusion Criteria:

1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:

Histologically or cytologically confirmed advanced solid tumors, including the

1. Melanoma (excluding uveal melanoma)

2. Cervical carcinoma

3. Pancreatic carcinoma

4. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2

5. Hepatocellular carcinoma

6. Urothelial carcinoma

7. Squamous cell carcinoma of the head and neck

8. Nasopharyngeal carcinoma

9. Renal cell carcinoma

10. Colorectal carcinoma

11. Endometrial carcinoma


13. Small cell lung cancer

14. Gastric or gastroesophageal junction adenocarcinoma

15. Sarcoma

2. Subjects in Part B (expansion) must have a diagnosis of any of the following:

Histologically or cytologically confirmed advanced solid tumors of the following

1. Non-squamous NSCLC

2. Melanoma

3. HNSCC, including NPC

4. CRC

5. UPS, including other select high grade STS, such as MFS

Prior to enrolling into Part B (expansion), subjects should have received
disease-specific standard therapy as indicated for:

1. Non-squamous NSCLC

2. Melanoma

3. HNSCC, including NPC

4. CRC

5. UPS, including other select high-grade STS such as MFS

3. All subjects' cancer must have progressed after treatment with standard/approved
therapies or have no appropriate available therapies.

4. Subjects must have measurable disease by RECIST 1.1.

5. All subjects must have adequate archival tumor sample (slides or archival FFPE
block[s] containing tumor.

6. All subjects in Part B (dose expansion) must have a tumor lesion that can be biopsied
at acceptable risk (in the judgment of the Investigator) and must agree to both a
fresh biopsy during screening and a second biopsy following treatment.

7. Subjects have an ECOG performance status of 0-1.

Exclusion Criteria:

1. Currently receiving other anticancer therapies

2. Prior treatment with an investigational anti-ICOS therapy

3. Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study

4. Treatment with nivolumab within 4 weeks of the start of study drug

5. Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A -

6. Treatment with any other anticancer therapy within 2 weeks of the start of study drug
(ie, other immunotherapy, chemotherapy, radiation therapy, etc.)

7. A life-threatening (Grade 4) irAE related to prior immunotherapy

8. Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for
endocrinopathies that are on stable hormone replacement doses

9. Failure to recover from any other toxicity (other than immune-related toxicity)
related to previous anticancer treatment to Grade ≤ 2

10. 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.

11. Active known or suspected autoimmune disease

12. Receipt of an organ allograft

13. 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

14. Treatment with antibiotics within 14 days prior to first dose of study drug

15. 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).

16. Treatment with ipilimumab within 4 weeks of the start of study drug
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: David Liebowitz, MD

Role: Study Director

Affiliation: Xencor, Inc.

Overall Contact

Name: David Liebowitz, MD

Phone: 858-617-6160



Facility Status Contact
UC San Diego Moores Cancer Center
San Diego, California 92093
United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado 80045
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Emory University
Atlanta, Georgia 30322
United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri 63110
United States
Active, not recruiting
Columbia University Medical Center
New York, New York 10032
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Mary Crowley Cancer Research - Medical City
Dallas, Texas 75230
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia 22903
United States
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States