Active — Not RecruitingPhase 1/2

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

United States523 participantsStarted 2017-12-12

Plain-language summary

First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer were enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity. A QTc sub-study was added for the UPLIFT cohort for a sub-set of sites.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Absolute neutrophil count (ANC) ≥1500 cells/mm3
. Platelet count ≥100,000/mm3
. Hemoglobin ≥9 g/dL
. In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institution's upper limit of normal (ULN). Patients on anticoagulation therapy are allowed if their relevant laboratory values are within the therapeutic window.
. Estimated glomerular filtration rate (GFR) ≥45 mL/min
. Total bilirubin ≤ULN
. g. Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia (e.g., hereditary spherocytosis, sickle cell disease, thalassemia intermedia) may be eligible after discussion with the Sponsor Medical Monitor.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DES: Maximum tolerated dose or recommended Phase 2 dose

Timeframe: Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met

DES and EXP: Safety and Tolerability

Timeframe: First dose up until 30 days after study termination

EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)

Timeframe: Every 6 weeks for up to 36 weeks

UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population

Timeframe: Every 8 weeks until disease progression or up to 24 months

QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values

Timeframe: 60 minutes prior to first dose, up to 26 hours after Cycle 3 dose

Trial details

NCT IDNCT03319628

SponsorMersana Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Platinum Resistant Ovarian Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Absolute neutrophil count (ANC) ≥1500 cells/mm3
. Platelet count ≥100,000/mm3
. Hemoglobin ≥9 g/dL
. In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institution's upper limit of normal (ULN). Patients on anticoagulation therapy are allowed if their relevant laboratory values are within the therapeutic window.
. Estimated glomerular filtration rate (GFR) ≥45 mL/min
. Total bilirubin ≤ULN
. g. Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia (e.g., hereditary spherocytosis, sickle cell disease, thalassemia intermedia) may be eligible after discussion with the Sponsor Medical Monitor.

What they're measuring

DES: Maximum tolerated dose or recommended Phase 2 dose

Timeframe: Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met

DES and EXP: Safety and Tolerability

Timeframe: First dose up until 30 days after study termination

EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)

Timeframe: Every 6 weeks for up to 36 weeks

UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population

Timeframe: Every 8 weeks until disease progression or up to 24 months

QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values

Timeframe: 60 minutes prior to first dose, up to 26 hours after Cycle 3 dose

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria