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

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


  • Org Study ID: XmAb20717-01
  • Secondary ID: DUET-2
  • NCT ID: NCT03517488
  • 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 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.

Overal Status Start Date Phase Study Type
Recruiting July 10, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Determine the safety and tolerability profile of XmAb20717

Primary Outcome 1 - Time Frame: 56 Days

Condition:

  • 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

Eligibility

Criteria:
Inclusion Criteria:

- Histologically or cytologically confirmed advanced solid tumors including:

- Melanoma (excluding uveal 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

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

- Have available archival formalin-fixed paraffin-embedded block(s) containing tumor or
at least 20 unstained slides containing tumor.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- 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.

- Failure to recover from any other toxicity (other than immune-related toxicity)
related to previous anticancer treatment to ≤ Grade 2.

- 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Barbara Hickingbottom, MD

Role: Study Director

Affiliation: Xencor, Inc.

Overall Contact

Name: Barbara Hickingbottom, MD

Phone: 858-480-3413

Email: bhickingbottom@xencor.com

Locations

Facility Status Contact
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California 90048
United States
Recruiting
UCLA Hematology-Oncology Clinic (Westwood)
Los Angeles, California 90095
United States
Recruiting
University of California San Diego Moores Cancer Center
San Diego, California 92093-0698
United States
Recruiting
University of California San Francisco Medical Center
San Francisco, California 94115
United States
Recruiting
Emory University
Atlanta, Georgia 30322
United States
Recruiting
University of Chicago Medicine
Chicago, Illinois 60637
United States
Recruiting
The University of Kansas Clinical Research Center
Fairway, Kansas 66205
United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United States
Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
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
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting