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Monoclonal Antibodies

XmAb®808 + Pembrolizumab for Advanced Cancers

Phase 1
Recruiting
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of using a drug combination to treat certain types of advanced cancer.

Who is the study for?
This trial is for adults with certain advanced cancers (like prostate, ovarian, lung, and more) that have worsened despite standard treatments. Participants must be in relatively good physical condition with a life expectancy over 3 months. They shouldn't have had severe reactions to immunotherapy before or be on other cancer treatments.Check my eligibility
What is being tested?
The study tests XmAb®808 combined with pembrolizumab (Keytruda®), both given through IV. It aims to find the safest and most effective dose of XmAb808 when used together with pembrolizumab in patients with specific types of advanced solid tumors.See study design
What are the potential side effects?
Possible side effects include typical immune therapy reactions like inflammation in different body parts, infusion-related symptoms, fatigue, skin issues, and potential complications from activating the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced, has spread, and didn't respond to standard treatments.
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My cancer is advanced, resistant to hormone therapy, and I haven't had PD1 therapy.
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My cancer can be measured by scans or has evaluable prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Duration of Response
Measurement of AUCtau
Measurement of Cmax
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumabExperimental Treatment2 Interventions
XmAb®808 in combination with pembrolizumab

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
29 Previous Clinical Trials
2,573 Total Patients Enrolled
Ben Thompson, MD PhDStudy DirectorXencor, Inc.

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05585034 — Phase 1
Colorectal Cancer Research Study Groups: Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
Colorectal Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05585034 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585034 — Phase 1

Frequently Asked Questions

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

Are there any open slots for enrolment in this medical experiment?

"Affirmative. Information from clinicaltrials.gov supports the notion that this medical test is in search of participants, with its original posting taking place on November 1st 2022 and most recent update occurring on November 28th 2022. This trial requires 220 individuals to be recruited at 3 distinct medical centres."

Answered by AI

How many individuals are being recruited for this medical research?

"Affirmative. Data found on clinicaltrials.gov confirms that this research, first made available to the public on November 1st 2022, is currently seeking participants. The researchers plan to enrol 220 patients from 3 sites in total."

Answered by AI

What key goals is this clinical trial hoping to achieve?

"This experiment, which is expected to take 49 days to complete, will assess the prevalence of Treatment-Emergent Adverse Events (TEAEs). Secondary objectives include Cmax – peak plasma concentration levels; Progression-Free Survival as established by RECIST 1.1 assessment and PCWG3 for those with prostate cancer; and AUCtau - area under the curve in regards to plasma concentrations versus time."

Answered by AI

How perilous are the effects of a Dose Escalation and Expansion XmAb808 combination treatment with pembrolizumab for patients?

"Power has assigned the safety of Dose Escalation and Expansion XmAb808 administered with pembrolizumab a score of 1 on account of it being an initial Phase 1 trial, which carries minimal evidence to support its efficacy or security."

Answered by AI
~147 spots leftby Dec 2027