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Monoclonal Antibodies

Upifitamab Rilsodotin for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Mersana Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Platinum-resistant disease
One to 4 prior lines of systemic therapy for ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after first response and every 8 weeks until disease progression or up to 24 months
Awards & highlights

Study Summary

This trial is testing the safety of a new antibody-drug conjugate (ADC) called XMT-1536 in patients with various types of cancer. The ADC will be administered as an IV infusion every 4 weeks. This study will also assess the ADC's activity and how it is metabolized by the body.

Who is the study for?
This trial is for adults with platinum-resistant ovarian cancer or non-small cell lung cancer who have measurable disease and are in good physical condition (ECOG 0 or 1). They must have adequate organ function, no severe heart rhythm problems, and not be on certain medications that affect liver enzymes. Pregnant women, those with untreated brain metastases, active infections like HIV or hepatitis B/C, severe diseases that could interfere with the study, a history of other cancers within 2 years (with some exceptions), or recent major surgery cannot participate.Check my eligibility
What is being tested?
The trial tests upifitamab rilsodotin (XMT-1536), an antibody-drug conjugate given intravenously every four weeks to patients whose tumors likely express NaPi2b. It includes dose escalation for safety assessment and expansion segments specifically for patients with platinum-resistant ovarian cancer and adenocarcinoma subtype of non-small cell lung cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion process itself as well as possible impacts on various organs due to the drug's mechanism of action. Specific side effects aren't listed but would typically relate to how this type of drug affects cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve with platinum-based chemotherapy.
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I have had 1 to 4 treatments for ovarian cancer.
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I have high-grade serous ovarian, fallopian tube, or peritoneal cancer that has spread or come back.
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I have had bevacizumab as part of my first or second line of treatment.
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I am fully active or can carry out light work.
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My blood tests and kidney function are within normal ranges, and I can make my own medical decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after first response and every 8 weeks until disease progression or up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after first response and every 8 weeks until disease progression or up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DES and EXP: Safety and Tolerability
DES: Maximum tolerated dose or recommended Phase 2 dose
EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
+2 more
Secondary outcome measures
DES and EXP: Anti-drug antibody and neutralizing antibody
DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)
DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin)
+8 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: QTc Sub-StudyExperimental Treatment1 Intervention
For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536. This cohort is closed to enrollment.
Group II: Pivotal Cohort (UPLIFT)Experimental Treatment1 Intervention
Patients with platinum-resistant ovarian cancer will receive XMT-1536 (upifitamab rilsodotin) to further confirm the efficacy. This cohort is closed to enrollment.
Group III: Dose Expansion - Ovarian CancerExperimental Treatment1 Intervention
Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.
Group IV: Dose Expansion - NSCLC adenocarcinomaExperimental Treatment1 Intervention
Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.
Group V: Dose EscalationExperimental Treatment1 Intervention
XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time. This cohort is closed to enrollment.

Find a Location

Who is running the clinical trial?

IQVIA BiotechIndustry Sponsor
18 Previous Clinical Trials
4,385 Total Patients Enrolled
1 Trials studying Ovarian Cancer
31 Patients Enrolled for Ovarian Cancer
PSI CROIndustry Sponsor
6 Previous Clinical Trials
1,735 Total Patients Enrolled
Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
765 Total Patients Enrolled
2 Trials studying Ovarian Cancer
350 Patients Enrolled for Ovarian Cancer

Media Library

upifitamab rilsodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03319628 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Dose Escalation, Dose Expansion - Ovarian Cancer, Dose Expansion - NSCLC adenocarcinoma, Pivotal Cohort (UPLIFT), QTc Sub-Study
Ovarian Cancer Clinical Trial 2023: upifitamab rilsodotin Highlights & Side Effects. Trial Name: NCT03319628 — Phase 1 & 2
upifitamab rilsodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03319628 — Phase 1 & 2

Frequently Asked Questions

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

In what regions is the research effort currently being conducted?

"This experiment is taking place in 15 various facilities, including Texas Oncology-Fort Worth Cancer Center (Fort Worth), VCU Massey Cancer Centre (Richmond) and Henry Ford Medical Centre (Detroit). The other sites are under wraps."

Answered by AI

Are there still openings available for participants in this clinical experiment?

"According to research published on clinicaltrials.gov, this medical experiment is in the process of recruiting patients who meet its criteria. The trial was first launched on December 12th 2017 and recently revised on October 18th 2022."

Answered by AI

To what extent is the public participating in this clinical experiment?

"This clinical trial requires 444 qualified patients to participate. They can access the treatment at Texas Oncology-Fort Worth Cancer Center in Fort Worth, Texas and VCU Massey Cancer Center in Richmond, Virginia."

Answered by AI

What goals is this trial attempting to reach?

"The primary aim of this medical research, which will be tracked over a maximum period of 24 months or until disease progression is documented, focuses on determining the anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin). Secondary objectives include analyzing the confirmed investigator-assessed objective response rate regardless of NaPi2b expression, monitoring tumor size to determine anti-neoplastic impacts, and assessing IRR for patients with high NaPi2b levels as well as overall."

Answered by AI
~72 spots leftby Mar 2025