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Monoclonal Antibodies

XmAb23104 + Ipilimumab for Solid Tumors (DUET-3 Trial)

Phase 1
Waitlist Available
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects in Part A (dose escalation) must have a diagnosis of histologically or cytologically confirmed advanced solid tumors including specific types
All subjects must have an ECOG performance status of 0-1
Must not have
Treatment with ipilimumab within 4 weeks of the start of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new drug, XmAb23104, to see if it is safe and effective at treating advanced solid tumors.

Who is the study for?
This trial is for adults with certain advanced solid tumors who've tried standard treatments. They must be relatively active (ECOG 0-1), expect to live more than 3 months, and have measurable disease. People can't join if they've had anti-ICOS therapy, recent ipilimumab or other cancer therapies, specific medical risks, or recent antibiotics/vaccines.
What is being tested?
The study tests XmAb23104 alone and combined with Yervoy (ipilimumab) in escalating doses to find the maximum tolerated dose. It aims to assess safety, how the body processes the drug (pharmacokinetics), immune response (immunogenicity), and preliminary effectiveness against tumors.
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as fatigue, diarrhea, skin rash, liver inflammation and potential infusion-related reactions. The severity of side effects may vary from mild discomforts to more serious conditions affecting organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an advanced solid tumor confirmed by a lab test.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not taken ipilimumab in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-related adverse events as assessed by CTCAE v4.03

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: XmAb®23104 MonotherapyExperimental Treatment1 Intervention
XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
Group II: XmAb®23104 Combination Therapy with IpilimumabExperimental Treatment2 Interventions
XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XmAb®23104
2019
Completed Phase 1
~200
Ipilimumab
FDA approved

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
30 Previous Clinical Trials
2,454 Total Patients Enrolled
4 Trials studying Melanoma
454 Patients Enrolled for Melanoma
ICON plcIndustry Sponsor
87 Previous Clinical Trials
28,683 Total Patients Enrolled
3 Trials studying Melanoma
350 Patients Enrolled for Melanoma
Chet Bohac, MD, MScStudy DirectorXencor, Inc.
David Liebowitz, MDStudy DirectorXencor, Inc.
2 Previous Clinical Trials
202 Total Patients Enrolled
Ben Thompson, MD, PhDStudy DirectorXencor, Inc.

Media Library

XmAb®23104 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03752398 — Phase 1
Melanoma Research Study Groups: XmAb®23104 Combination Therapy with Ipilimumab, XmAb®23104 Monotherapy
Melanoma Clinical Trial 2023: XmAb®23104 Highlights & Side Effects. Trial Name: NCT03752398 — Phase 1
XmAb®23104 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03752398 — Phase 1
~30 spots leftby Jan 2026
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