MelanomaPhase 1DUET-2NCT03517488
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
A Phase 1 study testing XmAb20717 in people with Melanoma and Breast Carcinoma, run by Xencor, Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Breast Carcinoma, Hepatocellular Carcinoma
- What is being tested?
- XmAb20717
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 17 sitesUnited States
- Study dates
- 10 Jul 2018to 6 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
- PART B (Dose Expansion Cohorts):
- Melanoma
- Renal cell carcinoma (clear cell predominant type)
- Non-small cell lung carcinoma
- Castrate-resistant adenocarcinoma of the prostate, defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL)
- Nasopharyngeal carcinoma
- Cholangiocarcinoma
- Basal cell carcinoma
- Squamous cell carcinoma of the anus
- Mesothelioma
- Ovarian or fallopian tube carcinoma
- Malignant adnexal neoplasms (including, but not limited to, sebaceous carcinoma, trichilemmal carcinoma, pilomatrix carcinoma, eccrine carcinoma, hidradenocarcinoma, adnexal carcinoma with divergent differentiation, papillary digital eccrine adenocarcinoma, microcystic adnexal carcinoma, and clear cell eccrine carcinoma)
- Thymoma
- Thymic carcinoma
- Squamous cell carcinoma of the penis
- Neuroendocrine carcinoma
- Vulvar cancer
- Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma)
- Subjects with other solid tumors for which there is published evidence of anti-tumor activity with anti-PD1/PDL1 and/or anti-CTLA4-directed therapy but for which there is no FDA-approved anti-PD1/PDL1 or CTLA4-directed checkpoint inhibitor treatment may be eligible for Part B after approval by the Medical Monitor.
- All subjects' cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies.
- Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.1.
- Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
- ECOG performance status of 0 - 1
- Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University
Atlanta, Georgia, 30322
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903
University of Chicago Medicine
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
UCLA Hematology-Oncology Clinic (Westwood)
Los Angeles, California, 90095
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center
Portland, Oregon, 97213
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California San Diego Moores Cancer Center
San Diego, California, 92093-0698
University of California San Francisco Medical Center
San Francisco, California, 94115
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
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.
- Conditions
- Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
- Being tested
- XmAb20717
- Keywords
- DUET-2, Melanoma, Triple Negative Breast Cancer, Hepatocellular Cancer, Urothelial Cancer, Renal Cell Cancer, Head and Neck Cancer, MSI-high Colorectal Cancer, MSI-high Endometrial Cancer, Non-small Cell Lung Cancer, Gastric Cancer, Gastroesophageal Junction Cancer, Mesothelioma, High-grade Neuroendocrine Cancer, Cervical Cancer, Small Cell Lung Cancer, Anal Cancer, Prostate Cancer, Nasopharyngeal Cancer, Bile Duct Cancer
- Medical subject headings
- Melanoma, Breast Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb20717Biological
Monoclonal bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| XmAb20717 | Experimental | XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles Receives: Biological: XmAb20717 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability profile of XmAb20717
Treatment-related adverse events as assessed by CTCAE v4.03
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start10 Jul 2018
- Primary completion1 Jun 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Zequn Tang, MD, Study director, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517488
- Sponsor's protocol ID
- XmAb20717-01
- Other IDs
- DUET-2
- Acronym
- DUET-2
- Status last verified
- Nov 2022
- First submitted
- 23 Apr 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03517488
- Acronym / sponsor ID
- DUET-2 / XmAb20717-01
- Conditions
- Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
- Keywords
- DUET-2, Melanoma, Triple Negative Breast Cancer, Hepatocellular Cancer, Urothelial Cancer, Renal Cell Cancer, Head and Neck Cancer, MSI-high Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XmAb20717 | Experimental | Biological: XmAb20717XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- 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;
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XmAb20717Monoclonal bispecific antibody | Biological | XmAb20717 |
Primary outcome
Determine the safety and tolerability profile of XmAb20717
Time frame: 56 Days
Treatment-related adverse events as assessed by CTCAE v4.03
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zequn Tang, MD study director
Xencor, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb20717 in people with Melanoma and Breast Carcinoma, run by Xencor, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety and tolerability profile of XmAb20717 (time frame: 56 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.