XMT-1536 (Upifitamab Rilsodotin) for Platinum-Sensitive Ovarian Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University Wexner Medical Center, Columbus, OHPlatinum-Sensitive Ovarian CancerXMT-1536 (Upifitamab Rilsodotin) - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial tests the safety of a new antibody-drug conjugate (XMT-1536) for ovarian cancer. The trial has two parts: a dose escalation portion to find a safe dose, and an expansion portion to study how well the drug works.

Eligible Conditions
  • Platinum-Sensitive Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Simvastatin 40mg
1
TILT-123
1
XMT-1660

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Every 8 weeks for the first 12 months, then every 12 weeks on treatment

Week 1
DES and EXP: Time of maximum observed concentration of carboplatin
Week 1
DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin)
Month 12
DES and EXP: Assess the correlation of tumor expression of NaPi2b and objective tumor response
Month 12
DES and EXP: Anti-neoplastic effects of XMT-1536 (Upifitamab rilsodotin) in combination with carboplatin PFS (by RECIST 1.1)
Every 90 days
DES and EXP: Anti-neoplastic effects of XMT-1536 (Upifitamab rilsodotin) in combination with carboplatin
DES and EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin) in combination with carboplatin
Day 30
DES and EXP: Safety and Tolerability, by observance of frequency and grade of adverse events based on CTCAE v5.0.
EXP: Assess the feasibility of Upifitamab rilsodotin combination initiated at MTD or RP2D
EXP: Assess the feasibility of upifitamab rilsodotin combination initiated at MTD
Week 24
DES: Maximum tolerated dose (MTD) for Upifitamab Rilsodotin with carboplatin
Week 1
DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)
DES and EXP: Area under the concentration curve of the last measurable concentration of carboplatin
DES and EXP: Maximum concentration of carboplatin
Week 1
DES and EXP: Maximum concentration of XMT-1536 (Upifitamab rilsodotin)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Simvastatin 40mg
1
TILT-123
1
XMT-1660

Trial Design

2 Treatment Groups

Dose Expansion - Module A (UPGRADE-A)
1 of 2
Dose Escalation - Module A (UPGRADE-A)
1 of 2

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: XMT-1536 (Upifitamab Rilsodotin) · No Placebo Group · Phase 1

Dose Expansion - Module A (UPGRADE-A)Experimental Group · 2 Interventions: XMT-1536 (Upifitamab Rilsodotin), Carboplatin · Intervention Types: Drug, Drug
Dose Escalation - Module A (UPGRADE-A)Experimental Group · 2 Interventions: XMT-1536 (Upifitamab Rilsodotin), Carboplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks for the first 12 months, then every 12 weeks on treatment

Who is running the clinical trial?

Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,453 Total Patients Enrolled
IQVIA BiotechIndustry Sponsor
18 Previous Clinical Trials
4,839 Total Patients Enrolled
PSI CROIndustry Sponsor
6 Previous Clinical Trials
2,148 Total Patients Enrolled
Robert Burger, MDStudy DirectorMersana Therapeutics
2 Previous Clinical Trials
794 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Where are the different places this trial is running?

"Presently, this clinical trial is looking for participants from 12 different sites. Some of these locations include Tucson, Columbus and Burlington. To reduce travel difficulties, it is best to select the site that is closest to your location." - Anonymous Online Contributor

Unverified Answer

Is there previous research to support the use of Carboplatin?

"Carboplatin was first trialed in 2002 at the H Central de Asturias medical facility. In the ensuing years, there have been 833 completed clinical trials worldwide. As of right now, 727 different carboplatin trials are actively recruiting patients; a large number of these studies are based in Tucson, Arizona." - Anonymous Online Contributor

Unverified Answer

How is Carboplatin most commonly employed in medical treatment?

"Carboplatin is most often used to treat non-hodgkin lymphoma. This chemotherapy can also be effective in treating advanced sarcoma, hodgkin disease, and certain cases of newly diagnosed cancer." - Anonymous Online Contributor

Unverified Answer

Are patients currently being enrolled in this trial?

"That is correct. By visiting clinicaltrials.gov, one can see that this trial was posted on 6/11/2021 and is still actively looking for participants. The study will have 48 patients total across 12 locations." - Anonymous Online Contributor

Unverified Answer

How many participants will this study have in total?

"Yes, as of 8/30/2022 this study is still recruiting participants. The trial was initially posted on 6/11/2021 and requires 48 patients from 12 different sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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