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

Phase 1

Completed

• Conditions: Platinum Resistant Ovarian Cancer; Non-Small Cell Adenocarcinoma
• Interventions: Drug: upifitamab rilsodotin

• Registration Number: NCT06517485
• 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 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. Enrollment into the EXP segment consisted of 2 parallel cohorts of patients to confirm the dose that was identified in DES and estimate the objective response rate in each patient population. 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: 2019-07-30
• Primary Completion: 2022-05-31
• Study Completion: 2022-08-03
• Status Verified: 2024-07
• 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: 142

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 Expansion - Ovarian Cancer	upifitamab rilsodotin	Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.
Dose Expansion - NSCLC adenocarcinoma	upifitamab rilsodotin	Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.

Primary Outcome Measures

Name	Time	Method
EXP: Safety and Tolerability	First dose up until 30 days after study termination	Evaluate incidence and severity of adverse events

Trial Locations

Locations (1)

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