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

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


  • Org Study ID: XmAb23104-01
  • Secondary ID: DUET-3
  • NCT ID: NCT03752398
  • NCT Alias:
  • Sponsor: Xencor, Inc. - Industry
  • Source: Xencor, Inc.

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 in subjects with selected advanced solid tumors.

Overal Status Start Date Phase Study Type
Recruiting May 1, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Treatment-related adverse events as assessed by CTCAE v4.03

Primary Outcome 1 - Time Frame: 56 Days

Condition:

  • 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

Eligibility

Criteria:
Inclusion Criteria:

1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:

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

2. Melanoma (excluding uveal melanoma)

3. Cervical carcinoma

4. Pancreatic carcinoma

5. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2
negative (TNBC)

6. Hepatocellular carcinoma

7. Urothelial carcinoma

8. Squamous cell carcinoma of the head and neck (HNSCC)

9. Nasopharyngeal carcinoma (NPC)

10. Renal cell carcinoma

11. Colorectal carcinoma

12. Endometrial carcinoma

13. NSCLC

14. Small cell lung cancer

15. Gastric or gastroesophageal junction adenocarcinoma

2. 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

3. All subjects' cancer must have progressed after treatment with standard/approved
therapies or have no appropriate available therapies.

4. Subjects must have measurable disease by RECIST 1.1.

5. 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.

6. Subjects have an ECOG performance status of 0-1.

Exclusion Criteria:

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: David Liebowitz, MD

Role: Study Director

Affiliation: Xencor, Inc.

Overall Contact

Name: David Liebowitz, MD

Phone: 858-617-6160

Email: dliebowitz@xencor.com

Locations

Facility Status Contact
Emory University
Atlanta, Georgia 30322
United States
Recruiting
Mary Crowley Cancer Research - Medical City
Dallas, Texas 75230
United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Emily Couric Clinical Cancer Center
Charlottesville, Virginia 22903
United States
Recruiting