Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion

Description

Summary

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

Official Title

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Keywords

Melanoma Breast Carcinoma Hepatocellular Carcinoma Urothelial Carcinoma Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma Colorectal Carcinoma Non-small Cell Lung Carcinoma Gastric or Gastroesophageal Junction Adenocarcinoma Endometrial Carcinoma Mesothelioma Neuroendocrine Carcinoma Cervical Cancer Small Cell Lung Carcinoma Squamous Cell Carcinoma of the Anus DUET-2 Triple Negative Breast Cancer Hepatocellular Cancer Urothelial Cancer Bladder Cancer Renal Cell Cancer Head and Neck Cancer MSI-high Colorectal Cancer MSI-high Endometrial Cancer Non-small Cell Lung Cancer Gastric Cancer Gastroesophageal Junction Cancer High-grade Neuroendocrine Cancer Small Cell Lung Cancer Anal Cancer Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Carcinoma, Hepatocellular Uterine Cervical Neoplasms Carcinoma, Renal Cell Breast Neoplasms Lung Neoplasms Carcinoma, Transitional Cell Squamous Cell Carcinoma of Head and Neck Carcinoma, Non-Small-Cell Lung Endometrial Neoplasms Colorectal Neoplasms Esophageal Neoplasms Carcinoma, Neuroendocrine Anus Neoplasms XmAb20717

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed diagnosis of advanced solid tumors including:
  • Melanoma;
  • Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
  • Hepatocellular carcinoma;
  • Urothelial carcinoma;
  • Squamous cell carcinoma of the head and neck;
  • Renal cell carcinoma (clear cell predominant type);
  • Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
  • Non-small cell lung carcinoma;
  • Gastric or gastroesophageal junction adenocarcinoma
  • Mesothelioma;
  • High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
  • Cervical cancer;
  • Squamous cell carcinoma of the anus
  • All subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.
  • Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You CAN'T join if...

  • Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
  • Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug.
  • Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent).
  • Subjects currently receiving other anticancer therapies.
  • Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
  • A life-threatening (Grade 4) immune-mediated adverse event related to prior immunotherapy.
  • Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1, except if previous immune-related endocrinopathy is medically managed with hormone replacement therapy only.
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
  • Have known active CNS metastases and/or carcinomatous meningitis. Participants 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, 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 (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).
  • Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted).
  • Receipt of an organ allograft.
  • Treatment with antibiotics within 14 days prior to first dose of study drug.

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego California 92093-0698 United States
  • UCLA Hematology-Oncology Clinic (Westwood) accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Xencor, Inc.
ID
NCT03517488
Phase
Phase 1
Study Type
Interventional
Last Updated