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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
Must not have
Any prior treatment with an investigational agent targeting CD28
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is advanced, has spread, and didn't respond to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have never been treated with experimental drugs targeting CD28.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
30 Previous Clinical Trials
2,432 Total Patients Enrolled
Ben Thompson, MD PhDStudy DirectorXencor, Inc.
Chet Bohac, MDStudy DirectorXencor, Inc.
3 Previous Clinical Trials
123 Total Patients Enrolled

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
~131 spots leftby Dec 2027
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