upifitamab rilsodotin for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasms+1 More
upifitamab rilsodotin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Malignant Neoplasms
  • Platinum-resistant Ovarian Cancer (PROC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasms

Study Objectives

5 Primary · 13 Secondary · Reporting Duration: Every 8 weeks until disease progression or up to 24 months

Month 24
UPLIFT: Duration of objective response (DOR)
Hour 26
QTc Sub-Study: Evaluation of the effect of XMT-1536 on QTcF in patients with platinum-resistant HGSOC by timepoint analysis
QTc Sub-Study: Evaluation of the effect of XMT-1536 on the PR-interval (PR), QRS duration (QRS), Heart Rate (HR), and ECG morphology
QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values
Week 1
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)
DES and EXP: Time of maximum observed concentration of XMT-1536 (upifitamab rilsodotin)
Week 36
DES and EXP: Anti-drug antibody and neutralizing antibody
DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
Month 24
UPLIFT: Confirmed Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
UPLIFT: Confirmed objective response rate by independent radiology review (IRR) for patients with high NaPi2b and overall
UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population
UPLIFT: Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression
UPLIFT: Objective response rate by independent radiology review (IRR) for patients with higher NaPi2b and overall
Day 30
DES and EXP: Safety and Tolerability
Day 60
UPLIFT: Incidence and severity of adverse events
Week 36
DES: Maximum tolerated dose or recommended Phase 2 dose

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasms

Trial Design

5 Treatment Groups

Pivotal Cohort (UPLIFT)
1 of 5
Dose Expansion - Ovarian Cancer
1 of 5
Dose Expansion - NSCLC adenocarcinoma
1 of 5
Dose Escalation
1 of 5
QTc Sub-Study
1 of 5
Experimental Treatment

444 Total Participants · 5 Treatment Groups

Primary Treatment: upifitamab rilsodotin · No Placebo Group · Phase 1 & 2

Pivotal Cohort (UPLIFT)
Drug
Experimental Group · 1 Intervention: upifitamab rilsodotin · Intervention Types: Drug
Dose Expansion - Ovarian Cancer
Drug
Experimental Group · 1 Intervention: upifitamab rilsodotin · Intervention Types: Drug
Dose Expansion - NSCLC adenocarcinoma
Drug
Experimental Group · 1 Intervention: upifitamab rilsodotin · Intervention Types: Drug
Dose Escalation
Drug
Experimental Group · 1 Intervention: upifitamab rilsodotin · Intervention Types: Drug
QTc Sub-Study
Drug
Experimental Group · 1 Intervention: upifitamab rilsodotin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks until disease progression or up to 24 months

Who is running the clinical trial?

Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,030 Total Patients Enrolled
IQVIA BiotechIndustry Sponsor
18 Previous Clinical Trials
4,443 Total Patients Enrolled
PSI CROIndustry Sponsor
5 Previous Clinical Trials
1,704 Total Patients Enrolled
Robert Burger, MDStudy DirectorMersana Therapeutics
2 Previous Clinical Trials
398 Total Patients Enrolled
Leslie DeMars, MDStudy DirectorMersana Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You have measurable disease as per RECIST, version 1.1.
You have an estimated glomerular filtration rate (GFR) of 45 mL/min or greater.
You have received prior therapy or surgical procedures that are expected to cause a severe or life-threatening acute toxic effect
ANC > 1500 cells/mm3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.