Melanoma (Excluding Uveal Melanoma)Phase 1DUET-3NCT03752398
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
A Phase 1 study testing XmAb®23104 and Yervoy® (ipilimumab) in people with Melanoma (Excluding Uveal Melanoma) and Cervical Carcinoma, run by Xencor, Inc. at 18 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 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma
- What is being tested?
- XmAb®23104 and Yervoy® (ipilimumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 18 sitesUnited States
- Study dates
- 1 May 2019to 15 Feb 2024
- 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
- 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:
- Melanoma (excluding uveal melanoma)
- Cervical carcinoma
- Pancreatic carcinoma
- Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
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- Hepatocellular carcinoma
- Urothelial carcinoma
- Squamous cell carcinoma of the head and neck
- Nasopharyngeal carcinoma
- Renal cell carcinoma
- Colorectal carcinoma
- Endometrial carcinoma
- NSCLC
- Small cell lung cancer
- Gastric or gastroesophageal junction adenocarcinoma
- Sarcoma
- 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:
- Non-squamous NSCLC
- Melanoma
- HNSCC, including NPC
- CRC
- UPS, including other select high grade STS, such as MFS
- ccRCC
- Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
- Non-squamous NSCLC
- Melanoma
- HNSCC, including NPC
- CRC
- UPS, including other select high-grade STS such as MFS
- RCC, clear cell histology (ccRCC)
- Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch repair CRC with the following:
- cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies
- subjects will have life expectancy greater than 3 months
- All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
- Subjects must have measurable disease by RECIST 1.1.
- All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
- 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.
- Subjects have an ECOG performance status of 0-1.
Who cannot join
- Currently receiving other anticancer therapies
- Prior treatment with an investigational anti-ICOS therapy
- Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
- Treatment with nivolumab within 4 weeks of the start of study drug
- Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
- Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
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- A life-threatening (Grade 4) irAE related to prior immunotherapy
- Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for endocrinopathies that are on stable hormone replacement doses
- Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
- 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.
- Active known or suspected autoimmune disease
- Receipt of an organ allograft
- 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
- Treatment with antibiotics within 14 days prior to first dose of study drug
- 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).
- Treatment with ipilimumab within 4 weeks of the start of study drug
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903
Mary Crowley Cancer Research - Medical City
Dallas, Texas, 75230
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Duke Cancer Institute
Durham, North Carolina, 27710
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania Abramson Cancer Center
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
UC San Diego Moores Cancer Center
San Diego, California, 92093
Florida Cancer Specialists
Sarasota, Florida, 34232
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 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 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.
- Conditions
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Hepatocellular Carcinoma, Urothelial Carcinoma
- Being tested
- XmAb®23104, Yervoy® (ipilimumab)
- Keywords
- DUET-3, Advanced solid tumors, 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, Small Cell Lung Cancer, Gastric Cancer, Gastroesophageal Junction Cancer, Sarcoma
- Medical subject headings
- Melanoma, Uterine Cervical Neoplasms, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb®23104Biological
Monoclonal bispecific antibody
Yervoy® (ipilimumab)Biological
Monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| XmAb®23104 Monotherapy | Experimental | XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles Receives: Biological: XmAb®23104 |
| XmAb®23104 Combination Therapy with Ipilimumab | Experimental | XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab) Receives: Biological: XmAb®23104; Biological: Yervoy® (ipilimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events as assessed by CTCAE v4.03
Safety and tolerability
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 posted26 Nov 2018
- Study start1 May 2019
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Excluding Uveal Melanoma)Studies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Chet Bohac, MD, MSc, Study director, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752398
- Sponsor's protocol ID
- XmAb23104-01
- Other IDs
- DUET-3
- Acronym
- DUET-3
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2018
- Last updated
- 5 Jul 2024
- 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 5 Jul 2024. 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®23104 in Subjects With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03752398
- Acronym / sponsor ID
- DUET-3 / XmAb23104-01
- Conditions
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative, Hepatocellular Carcinoma, Urothelial Carcinoma
- Keywords
- DUET-3, Advanced solid tumors, Melanoma, Cervical Cancer, Pancreatic Cancer, Triple Negative Breast Cancer, Hepatocellular/Liver Cancer, Urothelial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 26 Nov 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XmAb®23104 Monotherapy | Experimental | Biological: XmAb®23104XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles |
| XmAb®23104 Combination Therapy with Ipilimumab | Experimental | Biological: XmAb®23104, Biological: Yervoy® (ipilimumab)XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
- Subjects in Part B (expansion) must have a diagnosis of any of the following:
- Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
- Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch repair CRC with the following:
- All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
Key exclusion criteria (16 listed)
- Currently receiving other anticancer therapies
- Prior treatment with an investigational anti-ICOS therapy
- Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
- Treatment with nivolumab within 4 weeks of the start of study drug
- Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
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 |
|---|---|---|
| XmAb®23104Monoclonal bispecific antibody | Biological | XmAb®23104 Combination Therapy with Ipilimumab, XmAb®23104 Monotherapy |
| Yervoy® (ipilimumab)Monoclonal antibody | Biological | XmAb®23104 Combination Therapy with Ipilimumab |
Primary outcome
Treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 56 Days
Safety and tolerability
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 5 Jul 2024.
- 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.
Chet Bohac, MD, MSc study director
Xencor, Inc.
18 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 XmAb®23104 and Yervoy® (ipilimumab) in people with Melanoma (Excluding Uveal Melanoma) and Cervical Carcinoma, run by Xencor, Inc. at 18 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 40 inclusion and 16 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Treatment-related adverse events as assessed by CTCAE v4.03 (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 5 Jul 2024.