NCT06517485

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

A Phase 1b/2, First-in-Human, Dose Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Mersana Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Platinum Resistant Ovarian Cancer
• Non-Small Cell Adenocarcinoma

Interventions

Type	Name	Description
DRUG	upifitamab rilsodotin	XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536

Timeline

• Start date: 2019-07-30
• Primary completion: 2022-05-31
• Completion: 2022-08-03
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study