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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
Subjects in Part C (expansion) must have a diagnosis of MSS or proficient mismatch repair CRC with specific criteria including life expectancy greater than 3 months, measurable disease, and adequate archival tumor sample
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights

DUET-3 Trial 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.Check my eligibility
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.See study design
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.

DUET-3 Trial 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.
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I have colorectal cancer with MSS or proficient mismatch repair, measurable disease, and a life expectancy over 3 months.
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I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I have an advanced solid tumor and have undergone standard treatment for it.

DUET-3 Trial 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

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

DUET-3 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)

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
29 Previous Clinical Trials
2,493 Total Patients Enrolled
ICON plcIndustry Sponsor
79 Previous Clinical Trials
22,824 Total Patients Enrolled
David Liebowitz, MDStudy DirectorXencor, Inc.
2 Previous Clinical Trials
318 Total Patients Enrolled

Media Library

XmAb®23104 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03752398 — Phase 1
Nasopharyngeal Cancer Research Study Groups: XmAb®23104 Combination Therapy with Ipilimumab, XmAb®23104 Monotherapy
Nasopharyngeal Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many clinical centers are conducting this experiment?

"The trial is actively enrolling patients in University of Michigan (Ann Arbor, MI), University of Iowa Hospitals and Clinics (Iowa City, IA), and Seattle Cancer Care Alliance (Seattle, WA) among 16 other locations."

Answered by AI

What other scientific endeavors have investigated XmAb®23104?

"Currently, there are 318 ongoing clinical trials for XmAb®23104 with 38 studies in their final stage. Most of the research sites are based out of Pittsburgh, Pennsylvania - but a total of 20362 locations all around the world have been approved to administer this medication."

Answered by AI

How many participants are currently partaking in this experiment?

"For this experiment to be successful, 234 participants meeting the inclusionary criteria must partake. ICON plc is funding and managing this trial through various medical centres such as University of Michigan in Ann Arbor, MI and University of Iowa Hospital & Clinics at Iowa City, IA."

Answered by AI

Has XmAb®23104 been granted authorization from the FDA?

"Our team evaluated the safety of XmAb®23104 on a 1-3 scale and gave it a score of 1. This is because this Phase 1 trial has minimal data to support its efficacy and safety."

Answered by AI

Are there still vacancies available for participation in this clinical trial?

"Confirmed. The research hosted on clinicaltrials.gov confirms that this medical study, which was initially posted in May 1st 2019, is actively recruiting participants. A total of 234 patients need to be enrolled from 16 distinct sites."

Answered by AI

What indications is XmAb®23104 regularly prescribed to treat?

"XmAb®23104 is mainly employed to treat cutaneous melanoma, yet can also assist with complete resection, liver carcinoma, and metastatic melanoma."

Answered by AI
~36 spots leftby Dec 2024