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.

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Updated on 6 February 2022

See if I qualify

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 Identifier	NCT03752398
Sponsor	Xencor, Inc.
Last Modified on	6 February 2022

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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

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cancer

monoclonal antibodies

estrogen

measurable disease

carcinoma

squamous cell 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

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