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Monoclonal Antibodies

Dose escalation and Dose Expansion of XmAb541 for Testicular Cancer

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 performance status of 0-2

Age ≥ 18 years. For subjects with GCTs, age ≥15 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 28

Awards & highlights

Study Summary

This trial aims to test a new drug, XmAb541, to see if it is safe and well-tolerated. Researchers also want to find the best and safest dose of the drug for future

Who is the study for?

Adults with advanced solid tumors, specifically ovarian, fallopian tube, peritoneal cancer, endometrial cancer or germ cell tumors (GCT), who have progressive disease despite standard treatments. Participants must be over 18 years old (15 for GCT), have good organ function and a life expectancy of at least 3 months.Check my eligibility

What is being tested?

The trial is testing the safety and tolerability of XmAb541 to find the best dose for future studies. It will also assess how well XmAb541 works against these types of cancers.See study design

What are the potential side effects?

As this is an early-phase study primarily focused on safety and optimal dosing, specific side effects are not listed but may include typical reactions to new cancer drugs such as fatigue, nausea, inflammation or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I am at least 18 years old, or at least 15 with germ cell tumors.

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My cancer is advanced and affects the ovaries, fallopian tubes, peritoneum, endometrium, or GCT.

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My tumor tests positive for CLDN6.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 28 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 Adverse Events

Incidence of cytokine release syndrome (CRS)

Incidence of dose-limiting toxicities (DLTs)

Secondary outcome measures

Changes in Circulating Tumor DNA (ctDNA)

Duration of Response

Measurement of Cmax

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose escalation and Dose Expansion of XmAb541Experimental Treatment1 Intervention

Intravenous or Subcutaneous administration

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,541 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA granted approval for the administration of increasing doses and expanding doses of XmAb541?

"Based on our evaluation at Power, the safety rating for Dose escalation and Dose Expansion of XmAb541 is graded as 1. This assessment aligns with it being a Phase 1 trial, denoting limited data backing its safety and effectiveness."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"Per Xencor, Inc., the primary endpoint for this research, to be evaluated from Day 1 through Day 28, is Adverse Event Occurrence. Besides the main outcome, secondary endpoints will encompass Area under curve (AUC) measurement representing plasma concentration versus time dynamics, Objective Response Rate determined by RECIST 1.1 criteria using CT/MRI imaging assessment and Duration of Response based on RECIST 1.1 CT/MRI imaging evaluation of response duration."

Answered by AI

What is the current number of individuals receiving medical intervention in this research study?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment efforts for this trial. The trial was initially posted on April 4th, 2024, and last updated on April 16th, 2024. The study aims to enroll a total of 212 participants from a single site."

Answered by AI

Is the enrollment process currently open for this research study?

"The clinical trial, currently open for enrollment according to details on clinicaltrials.gov, was initially listed on April 4th, 2024 and most recently revised on April 16th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors

2024. "Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06276491.

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