A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors

Xencor, Inc.18 sites in 1 country198 target enrollmentMay 1, 2019

ConditionsMelanoma (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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Melanoma (Excluding Uveal Melanoma)
Sponsor: Xencor, Inc.
Enrollment: 198
Locations: 18
Primary Endpoint: Treatment-related adverse events as assessed by CTCAE v4.03
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

February 15, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Xencor, Inc.

Responsible Party

Sponsor

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
•Hepatocellular carcinoma
•Urothelial carcinoma
•Squamous cell carcinoma of the head and neck
•Nasopharyngeal carcinoma

Exclusion Criteria

•Currently receiving other anticancer therapies
•Prior treatment with an investigational anti-ICOS therapy
•Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
•Treatment with nivolumab within 4 weeks of the start of study drug
•Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
•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, except for endocrinopathies that are on stable hormone replacement doses
•Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
•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.