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

  • End date
    Dec 26, 2024
  • participants needed
  • sponsor
    Xencor, Inc.
Updated on 6 February 2022
monoclonal antibodies
measurable disease
squamous cell carcinoma
lung cancer
treatment regimen
solid tumour
breast carcinoma
squamous cell carcinoma of head and neck
transitional cell carcinoma
cervical carcinoma
nasopharyngeal carcinoma
endometrial carcinoma
formalin-fixed paraffin-embedded
head and neck carcinoma
lung carcinoma
gastroesophageal junction adenocarcinoma
bispecific antibody
urothelial carcinoma


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.

Condition 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
Treatment XmAb®23104, Yervoy® (ipilimumab)
Clinical Study IdentifierNCT03752398
SponsorXencor, Inc.
Last Modified on6 February 2022


Yes No Not Sure

Inclusion Criteria

Subjects in Part A (dose escalation) must have a diagnosis of any of the following
Histologically or cytologically confirmed advanced solid tumors, including the
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
Small cell lung cancer
Gastric or gastroesophageal junction adenocarcinoma
Subjects in Part B (expansion) must have a diagnosis of any of the following
Histologically or cytologically confirmed advanced solid tumors of the
Non-squamous NSCLC
HNSCC, including NPC
UPS, including other select high grade STS, such as MFS
All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies
Subjects must have measurable disease by RECIST 1.1
Prior to enrolling into Part B (expansion), subjects should have received
disease-specific standard therapy as indicated for
All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor
Non-squamous NSCLC
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
Subjects have an ECOG performance status of 0-1
HNSCC, including NPC
UPS, including other select high-grade STS such as MFS
RCC, clear cell histology (ccRCC)

Exclusion Criteria

Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
Prior treatment with an investigational anti-ICOS therapy
Treatment with nivolumab within 4 weeks of the start of study drug
Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade 2
Currently receiving other anticancer therapies
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
Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
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
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 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)
Treatment with ipilimumab within 4 weeks of the start of study drug
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note