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Monoclonal Antibodies

XmAb®22841 for Solid Tumors (DUET-4 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 the combination cohorts in Part A with XmAb22841 and pembrolizumab may have an advanced solid tumor that either: has progressed after treatment with all available therapies that are known to confer clinical benefit, or is intolerant or has refused standard treatment (as for the XmAb22841 monotherapy cohorts), or is of a tumor type for which pembrolizumab is an approved indication and has not previously been treated with an agent targeting PD1 or PDL1.

PART B (Dose Expansion Cohorts): XmAb22841 Single Agent Cohort: Must have histologically or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with all available therapies that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Eligible tumor types include the following: Anti-PD1 refractory melanoma (or any uveal melanoma), Anti-PD1 refractory NSCLC, Anti-PD1 refractory renal cell carcinoma (with clear cell component), Anti-PD1 refractory urothelial carcinoma, Head and neck squamous cell carcinoma, Hepatocellular carcinoma, Gastric adenocarcinoma, Cervical carcinoma, Breast carcinoma that is estrogen receptor, progesterone receptor, and HER2 negative (TNBC), Epithelial ovarian cancer, Nasopharyngeal carcinoma, Squamous cell anal carcinoma, Squamous cell penile carcinoma, Squamous cell vulvar carcinoma.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

DUET-4 Trial Summary

This trial is testing a new drug, XmAb22841, to see if it is safe and works well against cancer when given alone or with another drug, pembrolizumab.

Eligible Conditions

Advanced or Metastatic Solid Tumors
Squamous Cell Carcinoma
Nasopharyngeal Cancer
Kidney Cancer
Non-Small Cell Lung Cancer
Breast Cancer
Vulvar Squamous Cell Carcinoma
Melanoma
Ovarian Cancer
Cervical Cancer
Anal Cancer
Colorectal Cancer
Pancreatic Cancer
Liver Cancer
Bladder Cancer
Peritoneal Carcinoma
Endometrial Cancer
Gastric Cancer
Intrahepatic Cholangiocarcinoma
Penile Cancer
Small Cell Lung Cancer
Prostate Cancer

DUET-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have a type of advanced cancer that has either not responded to other treatments, or you cannot tolerate the standard treatment, or you have not received a type of medication that targets PD1 or PDL1.

Select...

You have a confirmed advanced or metastatic solid tumor that has not responded to all available treatments that are known to help, or you cannot tolerate treatment, or you do not want to have standard treatment. You have one of these eligible types of tumors: melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, hepatocellular carcinoma, gastric adenocarcinoma, cervical carcinoma, triple-negative breast carcinoma, epithelial ovarian cancer, nasopharyngeal carcinoma, squamous cell anal carcinoma, squamous cell penile carcinoma, or squamous cell vulvar carcinoma.

Select...

You have been diagnosed with advanced or metastatic cancer in one of the following areas: skin, cervix, pancreas, breast, liver, bladder, head and neck, nasopharynx, kidney, colon, uterus, lung, stomach, prostate, or ovaries.

DUET-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

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

Safety and tolerability profile of XmAb22841 assessed by rates of treatment-related adverse events (AEs), graded by CTCAE v4.03.

DUET-4 Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment2 Interventions

Arm 2: Combination of XmAb®22841 and Pembrolizumab (Keytruda®)

Group II: Arm 1Experimental Treatment1 Intervention

Arm 1: XmAb®22841 Monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XmAb®22841

2019

Completed Phase 1

~80

Pembrolizumab (Keytruda®)

2019

Completed Phase 1

~140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,675 Total Patients Enrolled

ICON Clinical ResearchIndustry Sponsor

49 Previous Clinical Trials

15,294 Total Patients Enrolled

Benjamin Thompson, MD, PhDStudy DirectorXencor, Inc.

1 Previous Clinical Trials

4 Total Patients Enrolled

Frequently Asked Questions

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

What therapeutic applications is XmAb®22841 regularly employed for?

"XmAb®22841 is a promising therapeutic for treating malignant neoplasms. It can also be used to combat unresectable melanoma, microsatellite instability high conditions, and disease progression after chemotherapy."

Answered by AI

Is this experiment currently enrolling participants?

"Based on the clinicaltrials.gov listing, this research project is not currently looking for individuals to participate in their trial. The study was initially listed in May 2019 and last edited two days ago in late May 2022; however, there are 9205 other trials actively seeking participants as of now."

Answered by AI

Are there any records of precedent studies involving XmAb®22841?

"Currently, 963 different trials are underway to investigate the effects of XmAb®22841. Out of these studies, 122 have progressed to Phase 3. The majority of clinical investigations for this treatment occur in Houston, Texas; however many other sites across 35772 locations have also been enlisted as trial centres."

Answered by AI

To what degree is XmAb®22841 a risk for individuals?

"Research into the safety of XmAb®22841 is still in its infancy. Our team at Power estimates that this drug's security rating is a 1 out of 3 due to limited data supporting efficacy and safety."

Answered by AI

To what extent is this experiment being administered to participants?

"Unfortunately, this investigation is no longer enlisting participants. It was initially advertised on May 29th 2019 and the most recent update to its listing occurred on May 27th 2022. If you are looking for other possibilities, there are 8242 clinical trials recruiting individuals with melanoma and 963 studies actively enrolling people in XmAb®22841 experiments."

Answered by AI

How many test sites are conducting this experiment?

"This research is currently engaging with 28 different medical centres, such as UCSD Altman Clinical and Translational Research Institute Building (ACTRI) in La Jolla, UCSD Perlman Medical Offices in Los Angeles, and UC San Diego Moores Cancer Center in San Diego. Additionally, there are numerous other enrolment sites."

Answered by AI

Recent research and studies

Current Treatment Options in OncologyJournal

Refining Immuno-oncology Approaches in Metastatic Prostate Cancer: Transcending Current Limitations

Wong, Risa L., and Evan Y. Yu. 2021. “Refining Immuno-oncology Approaches in Metastatic Prostate Cancer: Transcending Current Limitations”. Current Treatment Options in Oncology. Springer Science and Business Media LLC. doi:10.1007/s11864-020-00808-x.

clinicaltrials.govStudy

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

2019. "A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03849469.