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XmAb23104

Phase 2

Melanoma (Excluding Uveal Melanoma) | Monoclonal antibody | Oncology |Xencor, Inc.|Trials Updated: Jul 5, 2024

XmAb23104 development status

Highest phase Phase 2 (NCT05879185)
Phase scored for XNCRPhase 1
Registered trials 2 across 2 sponsors since May 2001

XmAb23104 target and mechanism

Molecular targetICOS
Target classCheckpoint
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment198

FDA Designations

No designations recorded

XmAb23104 clinical trials

XmAb23104 · 1 trial · 16 indications

Phase 1 1
NCT03752398A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)Melanoma (Excluding Uveal Melanoma)
COMPLETED198 Analytics
PHASE1COMPLETED
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
Melanoma (Excluding Uveal Melanoma)Unlock trial analytics

Study Endpoints

Primary Endpoints

Treatment-related adverse events as assessed by CTCAE v4.03
56 Days

Safety and tolerability

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XmAb®23104 MonotherapyEXPERIMENTALXmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
XmAb®23104 Combination Therapy with IpilimumabEXPERIMENTALXmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)

Interventions

NameTypeDescription
XmAb®23104BIOLOGICALMonoclonal bispecific antibody
Yervoy® (ipilimumab)BIOLOGICALMonoclonal antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. 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: 1. Melanoma (excluding uveal melanoma) 2. Cervical carcinoma 3. Pancreatic carcinoma 4...

Countries:United States
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Frequently asked questions about XmAb23104

What is XmAb23104?

XmAb23104 is an investigational monoclonal antibody developed by Xencor, Inc. for the treatment of advanced solid tumors. It is being studied in oncology, with melanoma (excluding uveal melanoma) as a listed indication. It remains in clinical development and is not an approved therapy.

What is XmAb23104 used for in melanoma?

XmAb23104 is being studied in melanoma excluding uveal melanoma, along with other advanced solid tumors. It is an investigational agent in Phase 1 development and has not been approved for any indication. Its melanoma evaluation occurred within a single completed Phase 1 trial.

What does XmAb23104 target?

XmAb23104 targets ICOS, an inducible T cell costimulatory receptor that belongs to the checkpoint target class. By binding ICOS, the monoclonal antibody is designed to act on a costimulatory pathway involved in T cell activation. Xencor engineered the molecule as an investigational oncology therapeutic.

Who makes XmAb23104?

Xencor, Inc. (ticker XNCR) is the developer of XmAb23104. The company designed the monoclonal antibody and sponsored its clinical evaluation in advanced solid tumors. XmAb23104 is also written as XmAb®23104.

What phase is XmAb23104 in?

XmAb23104 is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. Its clinical program consists of one completed Phase 1 trial, and no trials are currently active.

What clinical trials is XmAb23104 in?

XmAb23104 was evaluated in the Phase 1 DUET-3 study, NCT03752398, titled A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors. The trial enrolled 198 participants across sites in the United States and is completed. It was randomized and controlled, with biomarker-selected enrollment.

Is XmAb23104 the same as XmAb®23104?

Yes, XmAb23104 and XmAb®23104 refer to the same investigational monoclonal antibody from Xencor, Inc. The registered trademark symbol appears in the compound's formal styling and in the title of its Phase 1 DUET-3 trial, NCT03752398. Both names identify the same ICOS-targeted agent.