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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2025
  • participants needed
    234
  • sponsor
    Xencor, Inc.
Updated on 25 May 2021
Investigator
David Liebowitz, MD
Primary Contact
Florida Cancer Specialists (5.4 mi away) Contact
+14 other location
cancer
monoclonal antibodies
estrogen
measurable disease
carcinoma
squamous cell carcinoma
lung cancer
treatment regimen
progesterone
HER2
ipilimumab
adenocarcinoma
solid tumour
erbb2
breast carcinoma
squamous cell carcinoma of head and neck
sarcoma
transitional cell carcinoma
yervoy
cervical carcinoma
nasopharyngeal carcinoma
endometrial carcinoma
formalin-fixed paraffin-embedded
head and neck carcinoma
lung carcinoma
sarcomas
gastroesophageal junction adenocarcinoma
bispecific antibody
urothelial carcinoma

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.

Details
Condition Pancreatic Cancer, Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, Colorectal Cancer, Endometrial Carcinoma, Malignant neoplasm of kidney, Rectal disorder, Uterine Cancer, Carcinoma, Malignant Fibrous Histiocytoma, melanoma, Cervical Intraepithelial Neoplasia, Transitional cell carcinoma, Renal Cell Carcinoma, skin cancer, HEPATIC NEOPLASM, Nasopharyngeal Cancer, Small Cell Lung Cancer, HEPATOCELLULAR CARCINOMA, Metastatic Melanoma, Vulvar Dysplasia and Carcinoma, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Advanced Solid Tumors, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of Head and Neck, Advanced Malignancies, Gastric or Gastroesophageal Junction Adenocarcinoma, Islet Ce417ll Cancer, Kidney Cancer, Endometrial Cancer, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Urothelial Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, cervical carcinoma, clear cell renal cell carcinoma, nasopharyngeal carcinoma, colorectal cancers, nsclc, cancer of the pancreas, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, liver cell carcinoma, sclc, small cell carcinoma, small cell carcinoma of the lung, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative
Treatment XmAb®23104, Yervoy® (ipilimumab)
Clinical Study IdentifierNCT03752398
SponsorXencor, Inc.
Last Modified on25 May 2021

Eligibility

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
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
Gastric or gastroesophageal junction adenocarcinoma
Sarcoma
Subjects in Part B (expansion) must have a diagnosis of any of the following
Histologically or cytologically confirmed advanced solid tumors of the
types
following
Non-squamous NSCLC
Melanoma
HNSCC, including NPC
UPS, including other select high grade STS, such as MFS
CRC
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
All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor
disease-specific standard therapy as indicated for
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
Non-squamous NSCLC
Subjects have an ECOG performance status of 0-1
Melanoma
HNSCC, including NPC
CRC
UPS, including other select high-grade STS such as MFS

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
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