A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (NCT03752398) | Clinical Trial Compass
CompletedPhase 1
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
United States198 participantsStarted 2019-05-01
Plain-language 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 advanced solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-related adverse events as assessed by CTCAE v4.03
. 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.)
. 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