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 monotherapy and combination therapy with ipilimumab 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 Colorectal Neoplasms Endometrial Neoplasms Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms Histiocytoma, Malignant Fibrous Ipilimumab XmAb®23104 Yervoy® (ipilimumab) XmAb®23104 Monotherapy

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:

Histologically or cytologically confirmed advanced solid tumors, including the following:

  1. Melanoma (excluding uveal melanoma)
  2. Cervical carcinoma
  3. Pancreatic carcinoma
  4. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
  5. Hepatocellular carcinoma
  6. Urothelial carcinoma
  7. Squamous cell carcinoma of the head and neck
  8. Nasopharyngeal carcinoma
  9. Renal cell carcinoma
  10. . Colorectal carcinoma
  11. . Endometrial carcinoma
  12. . NSCLC
  13. . Small cell lung cancer
  14. . Gastric or gastroesophageal junction adenocarcinoma
  15. . Sarcoma
  16. 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. Melanoma
  3. HNSCC, including NPC
  4. CRC
  5. UPS, including other select high grade STS, such as MFS
  6. ccRCC

Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:

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

You CAN'T join if...

  1. Currently receiving other anticancer therapies
  2. Prior treatment with an investigational anti-ICOS therapy
  3. Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
  4. Treatment with nivolumab within 4 weeks of the start of study drug
  5. Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A -10A
  6. Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
  7. A life-threatening (Grade 4) irAE related to prior immunotherapy
  8. Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for endocrinopathies that are on stable hormone replacement doses
  9. Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
  10. . 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.
  11. . Active known or suspected autoimmune disease
  12. . Receipt of an organ allograft
  13. . 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
  14. . Treatment with antibiotics within 14 days prior to first dose of study drug
  15. . 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).
  16. . Treatment with ipilimumab within 4 weeks of the start 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