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Monoclonal Antibodies
XMT-1660 for Breast Cancer
Phase 1
Recruiting
Research Sponsored by Mersana Therapeutics
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 3 years
Awards & highlights
Study Summary
This trial will test the effects of XMT-1660 on advanced solid tumors.
Who is the study for?
This trial is for adults with certain advanced solid tumors like ovarian, breast, endometrial, fallopian tube, or peritoneal cancer. They should be in good physical condition (ECOG 0-1), have at least one measurable tumor lesion and agree to a biopsy if safe. Not eligible if they've had another cancer treatment within 2 years (except some skin cancers or localized treatments), severe diseases that could affect the study's process, major surgery or anticancer therapy too close to the start of this study, untreated brain metastases, or prior specific ADC treatments.Check my eligibility
What is being tested?
The clinical trial is testing XMT-1660's effectiveness on participants with various types of solid tumors. The main focus is to see how well it works against these cancers and what effects it has on patients' bodies.See study design
What are the potential side effects?
While not specified here, side effects from drugs like XMT-1660 typically include reactions at the injection site, fatigue, nausea and vomiting. There may also be risks associated with organ inflammation and potential impacts on blood cell counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with XMT-1660 during the first cycle of treatment (Dose Escalation)
Incidence of adverse events (Dose Escalation and Dose Expansion)
Objective Response Rate (ORR) (Dose Expansion)
Secondary outcome measures
Apparent terminal elimination half-life of XMT-1660 (Dose Expansion)
Area under the concentration-time curve of XMT-1660 (AUC) (Dose Expansion)
Assess antidrug antibodies (ADA) and neutralizing antibodies (nAB) (Dose Escalation and Dose Expansion)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: XMT-1660Experimental Treatment1 Intervention
Single arm XMT-1660 alone (monotherapy)
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Who is running the clinical trial?
Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
969 Total Patients Enrolled
Divya Gupta, MDStudy DirectorMersana Therapeutics
2 Previous Clinical Trials
176 Total Patients Enrolled
Dr. Shin, MDStudy DirectorMersana Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.I have a history of serious liver conditions.I have had a brain MRI recently or will have one due to my triple-negative breast cancer or symptoms/history of brain metastases.I do not have any severe illnesses that could worsen my condition or affect the study.My cancer has returned or spread and didn't respond to treatment or I couldn't tolerate the treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with a specific type of cancer drug called an ADC with auristatin.I haven't had active treatment for another cancer, except skin or certain breast/cervix cancers, in the last 2 years.I haven't had major surgery, cancer drugs, or palliative radiation within the specified times before starting the study.I have untreated brain metastases or a history of cancer spreading to the lining of my brain.I have not received treatment targeting B7-H4 before.I can provide a sample of my tumor for testing or am willing to have a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: XMT-1660
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has XMT-1660 been given the seal of approval by the Food and Drug Administration?
"Our team at Power assessed XMT-1660 on a 3 point scale and determined the safety of this drug is only supported by limited data, thus it was given 1 point."
Answered by AI
What objectives does this investigation seek to accomplish?
"This multi-year study is designed to measure the Duration of Response (DOR) as its primary objective. Secondary investigations include Volume of Distribution, Time of Maximum Observed Plasma Concentration and Systemic Clearance; all three are used to assess XMT-1660's pharmacokinetics."
Answered by AI
To what extent do the parameters of this trial allow for participant enrollment?
"In order to carry out the trial, 166 suitable participants are needed. Mersana Therapeutics is managing the study from various medical institutions such as New york University Langone Health in NYC and NEXT Oncology Virginia based in Fairfax, VA."
Answered by AI
Is recruitment for this trial currently underway?
"Affirmative. Clinicaltrials.gov records indicate that the trial, first posted on August 15th 2022 is actively recruiting volunteers. 166 people must be enrolled from 5 distinct medical sites for this research to succeed."
Answered by AI
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