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

Status: Active

Description

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 in subjects with selected advanced solid tumors.

Eligibility Criteria

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 (TNBC)
  • Hepatocellular carcinoma
  • Urothelial carcinoma
  • Squamous cell carcinoma of the head and neck (HNSCC)
  • Nasopharyngeal carcinoma (NPC)
  • Renal cell carcinoma
  • Colorectal carcinoma
  • Endometrial carcinoma
  • NSCLC
  • 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 following types:
  • Non-squamous NSCLC
  • TNBC
  • HNSCC
  • NPC
  • 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.
  • 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.

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 pembrolizumab within < 6 - 24 weeks prior to enrollment (cohort dependent)
  • Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
  • A life-threatening (Grade 4) IRAE related to prior immunotherapy
  • Failure to recover from any IRAE from prior cancer therapy to Grade ≤ 1
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
  • Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs)
  • 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

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Xencor, Inc.

Trial IDs

Primary ID XmAb23104-01
Secondary IDs NCI-2019-00828, DUET-3
Clinicaltrials.gov ID NCT03752398