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Monoclonal Antibodies

XmAb®662 + Pembrolizumab for Solid 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests a new therapy for advanced solid tumors to see if it is safe and effective.

Who is the study for?

This trial is for adults with advanced solid tumors that have grown after standard treatment. They must be able to measure the tumor's size, have a life expectancy of at least 3 months, and their body should be functioning well enough to participate. People can't join if they've had severe immune reactions from similar treatments or are currently on certain cancer therapies.Check my eligibility

What is being tested?

The study tests XmAb662 alone or with Keytruda (pembrolizumab) in patients with various types of advanced cancers. It aims to find a safe and effective dose by observing how patients react and how the drug behaves in their bodies.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting different organs, infusion-related reactions like allergic responses during drug administration, and other common side effects associated with cancer immunotherapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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 and severity of treatment emergent adverse events (TEAEs)

Incidence of dose-limiting toxicities (DLTs)

Secondary outcome measures

Characterization of pharmacokinetics

Duration of response

Objective response rate

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbabExperimental Treatment2 Interventions

Group II: Dose Escalation and Expansion XmAb662 administered as monotherapyExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,543 Total Patients Enrolled

Chet Bohac, MDStudy DirectorExecutive Medical Director, Clinical Development

3 Previous Clinical Trials

336 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05996445 — Phase 1

Solid Tumors Research Study Groups: Dose Escalation and Expansion XmAb662 administered as monotherapy, Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab

Solid Tumors Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05996445 — Phase 1

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05996445 — 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 openings available for this investigation at present?

"Clinicaltrials.gov indicates that this trial is currently enrolling patients; the study was first posted on July 28th of 2023 and updated only a few weeks ago, on August 10th."

Answered by AI

Has the single-drug regimen of XmAb662 been granted permission by FDA regulations?

"The safety of Dose Escalation and Expansion XmAb662 administered as monotherapy can be considered low, scoring a 1 on our team's scale. This is due to the limited data available for this Phase 1 trial regarding both efficacy and security."

Answered by AI

How many participants have been approved for this clinical investigation?

"Accurately, clinicaltrials.gov reveals that this trial currently needs participants; the initial posting was on July 28th 2023 and it was most recently updated on August 10th 2023. A total of 210 individuals are being accepted from one medical centre."

Answered by AI

What is the primary objective of this experimental research?

"This experiment, which will run for 3 weeks per participant, is mainly focused on the rate and severity of Treatment Emergent Adverse Events (TEAEs). Additionally, it seeks to measure Objective Response Rate according to RECIST 1.1 modified by PCWG3 in prostate cancer patients; Progression-free Survival also as defined by RECIST 1.1 with PCWG3 modifications; and Duration of Response under similar guidelines."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors

2023. "A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996445.