First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b
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ClinicalTrials.gov Identifier: NCT03319628 |
Recruitment Status :
Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : November 13, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | October 17, 2017 | ||||
First Posted Date ICMJE | October 24, 2017 | ||||
Last Update Posted Date | November 13, 2023 | ||||
Actual Study Start Date ICMJE | December 12, 2017 | ||||
Actual Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Maximum tolerated dose or recommended Phase 2 dose [ Time Frame: Up to 14 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met ] Evaluate adverse events and use of concomitant medication use after XMT-1536 doses
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b | ||||
Official Title ICMJE | A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b | ||||
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. 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. | ||||
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 study consisted of three segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). 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. Enrollment into the EXP segment consisted of 2 parallel cohorts of patients to confirm the dose that has been identified in DES and estimate the objective response rate in each patient population. The EXP and UPLIFT cohorts are 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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Open-label, dose escalation to reach MTD. The MTD will be confirmed in parallel cohorts: patients with platinum-resistant ovarian cancer; patients with non-squamous NSCLC, adenocarcinoma subtype Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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 Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
523 | ||||
Original Estimated Enrollment ICMJE |
120 | ||||
Estimated Study Completion Date ICMJE | October 31, 2024 | ||||
Actual Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | General Inclusion Criteria (for Dose Escalation, Expansion, and UPLIFT):
General Exclusion Criteria (for Dose Escalation, Expansion, and UPLIFT) :
Ovarian Cancer Inclusion Criteria for UPLIFT:
Ovarian Cancer Exclusion Criteria for UPLIFT:
Ovarian Cancer Inclusion Criteria for QTc sub-study: Note: patients must meet all UPLIFT cohort inclusion criteria in order to participate in the QTc sub-study • Study patient has agreed to remain in the clinic for the additional QTc related study activities on the Day 1 of Cycle 1 and Cycle 3. Ovarian Cancer Exclusion Criteria for QTc sub-study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Hungary, Italy, Lithuania, New Zealand, Norway, Poland, Spain, Sweden, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03319628 | ||||
Other Study ID Numbers ICMJE | XMT-1536-1 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Mersana Therapeutics | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Mersana Therapeutics | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Mersana Therapeutics | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |