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

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer Metastatic; Platinum Resistant Ovarian Cancer
• Interventions: Drug: upifitamab rilsodotin

• Registration Number: NCT06517433
• Lead Sponsor: Mersana Therapeutics

Brief 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. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity.

Detailed Description

This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) was administered as an intravenous infusion once every four weeks. The DES segment studied small groups of patients who received increased doses. A Safety Review Committee was established to review the data from each dose level before moving to the next higher dose. The dose escalation cohort has ended and is no longer enrolling patients. All adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Throughout the study, pharmacokinetics were measured using proprietary assays developed by Mersana. Anti-cancer activity were measured via RECIST.

Study Timeline

• Study Start: 2017-12-12
• Primary Completion: 2021-07-09
• Study Completion: 2021-07-09
• Status Verified: 2023-09
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	upifitamab rilsodotin	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.

Primary Outcome Measures

Name	Time	Method
DES and EXP: Safety and Tolerability	First dose up until 30 days after study termination	Evaluate incidence and severity of adverse events
DES: Maximum tolerated dose or recommended Phase 2 dose	Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met	Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses

Secondary Outcome Measures

Name	Time	Method
DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)	Every 6 weeks for up to 36 weeks	Monitor tumor size

Trial Locations

Locations (1)

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States