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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2024
  • participants needed
    234
  • sponsor
    Xencor, Inc.
Updated on 6 February 2022
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 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

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
following
types
Non-squamous NSCLC
Melanoma
HNSCC, including NPC
CRC
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
ccRCC
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
Melanoma
Subjects have an ECOG performance status of 0-1
HNSCC, including NPC
CRC
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

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