A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
DUET-2
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
2 other identifiers
interventional
150
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2018
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2018
CompletedStudy Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2022
CompletedDecember 1, 2022
November 1, 2022
3.9 years
April 23, 2018
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the safety and tolerability profile of XmAb20717
Treatment-related adverse events as assessed by CTCAE v4.03
56 Days
Study Arms (1)
XmAb20717
EXPERIMENTALXmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors:
- PART A (Dose Escalation Cohorts)
- 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
- +24 more criteria
You may not qualify if:
- Subjects currently receiving other anticancer therapies, with the exception of subjects with adenocarcinoma of the prostate, who may continue luteinizing hormone-releasing hormone (LHRH) analogue therapy.
- 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).
- Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.). Subjects with prostate cancer may continue LHRH analogue therapy.
- A life-threatening (Grade 4) immune-mediated AE 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.
- Prior treatment with any checkpoint inhibitor therapy regimen that targets both PD1/L1 and CTLA-4.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
- ICON plccollaborator
Study Sites (17)
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
UCLA Hematology-Oncology Clinic (Westwood)
Los Angeles, California, 90095, United States
University of California San Diego Moores Cancer Center
San Diego, California, 92093-0698, United States
University of California San Francisco Medical Center
San Francisco, California, 94115, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zequn Tang, MD
Xencor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2018
First Posted
May 7, 2018
Study Start
July 10, 2018
Primary Completion
June 1, 2022
Study Completion
September 6, 2022
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share