First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b (NCT03319628) | Clinical Trial Compass
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 range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
✓. 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.
Exclusion criteria
✕. Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response \[complete response/remission (CR) or partial response/remission (PR)\], and then progressed between 3 months and ≤ 6 months after the date of the last dose of platinum
What they're measuring
1
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
2
DES and EXP: Safety and Tolerability
Timeframe: First dose up until 30 days after study termination
3
EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)
Timeframe: Every 6 weeks for up to 36 weeks
4
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
5
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
✕. Patients who have received 2 to 4 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum