Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
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 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.

Official Title

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

Keywords

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 DUET-3 Melanoma Cervical Cancer Pancreatic Cancer Triple Negative Breast Cancer Hepatocellular/Liver Cancer Urothelial Cancer Bladder Cancer Renal Cell Cancer Head and Neck Cancer Colorectal Cancer Endometrial Cancer Non-small Cell Lung Cancer Gastric Cancer Gastroesophageal Junction Cancer Sarcoma Carcinoma Lung Neoplasms Small Cell Lung Carcinoma Breast Neoplasms Squamous Cell Carcinoma of Head and Neck Endometrial Neoplasms Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms Histiocytoma, Malignant Fibrous XmAb®23104

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
  2. Histologically or cytologically confirmed advanced solid tumors, including the following:
  3. Melanoma (excluding uveal melanoma)
  4. Cervical carcinoma
  5. Pancreatic carcinoma
  6. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (TNBC)
  7. Hepatocellular carcinoma
  8. Urothelial carcinoma
  9. Squamous cell carcinoma of the head and neck (HNSCC)
  10. Nasopharyngeal carcinoma (NPC)
  11. . Renal cell carcinoma
  12. . Colorectal carcinoma
  13. . Endometrial carcinoma
  14. . NSCLC
  15. . Small cell lung cancer
  16. . Gastric or gastroesophageal junction adenocarcinoma
  17. . Sarcoma
  18. 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:

  1. Non-squamous NSCLC
  2. TNBC
  3. HNSCC
  4. NPC
  5. UPS, including other select high grade STS, such as MFS
  6. All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
  7. Subjects must have measurable disease by RECIST 1.1.
  8. All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
  9. 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.
  10. Subjects have an ECOG performance status of 0-1.

You CAN'T join if...

  1. Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
  2. Prior treatment with an investigational anti-ICOS therapy
  3. Treatment with nivolumab within 4 weeks of the start of study drug
  4. Treatment with pembrolizumab within < 6 - 24 weeks prior to enrollment (cohort dependent)
  5. Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
  6. A life-threatening (Grade 4) IRAE related to prior immunotherapy
  7. Failure to recover from any IRAE from prior cancer therapy to Grade ≤ 1
  8. Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
  9. 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)
  10. . Receipt of an organ allograft
  11. . 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
  12. . Treatment with antibiotics within 14 days prior to first dose of study drug

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Providence Portland Medical Center accepting new patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Xencor, Inc.
ID
NCT03752398
Phase
Phase 1
Study Type
Interventional
Last Updated