A Study of XMT-1660 in Participants With Solid Tumors

March 19, 2024 updated by: Mersana Therapeutics

A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors

A Study of XMT-1660 in Solid Tumors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This first-in-human (FIH) study will test the safety and side effects of a drug called XMT-1660. A side effect is anything a drug does to the body besides treating the disease.

Participants in the study will have cancer that has come back after a period of time during which the cancer could not be detected (recurrent), spread in the body near where it started (advanced) or spread through the body (metastatic).

The study will have two parts. The first part called Dose Escalation will find out how much XMT-1660 should be given to participants. The second part called Dose Expansion will use the dose found in the first part to find out how safe XMT-1660 is and if it works to treat solid tumor cancers.

Study Type

Interventional

Enrollment (Estimated)

319

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health-Chao Family Comprehensive Cancer Center
        • Contact:
          • Ritesh Parajuli
        • Principal Investigator:
          • Ritesh Parajuli
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA
        • Contact:
          • Nicholas McAndrew, MD
        • Principal Investigator:
          • Nicholas McAndrew, MD
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Judy Wang
        • Principal Investigator:
          • Judy Wang
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Hyo Han, MD
        • Principal Investigator:
          • Hyo Han, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University
        • Contact:
          • Kevin Kalinsky, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Dario Roque, MD
        • Contact:
          • Dario Roque, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Antonio Giordano, MD, PhD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Gerburg Wulf, MD
        • Principal Investigator:
          • Gerburg Wulf, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health Hospital
        • Contact:
          • Amy Weise, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Nour Abuhadra, MD
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Langone Health
        • Contact:
          • Sylvia Adams, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center Oklahoma University Health
        • Principal Investigator:
          • Debra Richardson, MD
        • Contact:
          • Debra Richardson, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
          • David C. Starks, MD
        • Principal Investigator:
          • David C. Starks, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC
        • Contact:
          • Erika P Hamilton, MD
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Texas Oncology, P.A.
        • Principal Investigator:
          • Joyce O'Shaughnessy, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
          • Kristen Kelley, MD
        • Principal Investigator:
          • Kristen Kelley, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Oncology Virginia
        • Contact:
          • Alex Spira, MD, PhD
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Summit Cancer Centers
        • Contact:
          • Arvind Chaudhry, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recurrent or advanced solid tumor and has disease progression after treatment with available anti-cancer therapies known to confer benefit or is intolerant to treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • At least one measurable lesion(s) as defined by RECIST version 1.1.
  • Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1

  • Brain magnetic resonance imaging (MRI) during the Pre- Screening/Screening period unless obtained within 30 days prior to enrollment (based on standard clinical care), if they meet either of the following criteria:

    1. All participants with TNBC
    2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.

Exclusion Criteria:

  • Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.
  • Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy within 14 days of starting study treatment.
  • Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.

  • Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.

    1. Participants are eligible if CNS metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment.
    2. In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg daily prednisone (or equivalent). Anticonvulsants are allowed except for those drugs associated with liver toxicity
    3. Participants may be eligible if CNS lesions are asymptomatic, equivocal for metastases or do not require specific therapy in the opinion of the investigator
  • Prior B7-H4 targeted treatment.
  • History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.
  • Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.
  • Clinically significant cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XMT-1660
Single arm XMT-1660 alone (monotherapy)
Drug: XMT-1660
XMT-1660 will be administered through a vein in your arm or port catheter (intravenously)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (Dose Escalation and Dose Expansion)
Time Frame: 3 years
Assess the safety and tolerability of XMT-1660 by determining the number of patients with adverse events from date of first dose to 30 days post last dose
3 years
Objective Response Rate (ORR) (Dose Expansion)
Time Frame: approximately 3 years
The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
approximately 3 years
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with XMT-1660 during the first cycle of treatment (Dose Escalation)
Time Frame: 17 months
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XMT-1660
17 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) (Dose Escalation)
Time Frame: Up to approximately 3 years
The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Up to approximately 3 years
Time of maximum observed plasma concentration of XMT-1660 (Tmax) (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660
3 years
Maximum observed plasma concentration of XMT-1660 (Cmax) (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660
3 years
Area under the concentration-time curve of XMT-1660 (AUC) (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660
3 years
Systemic clearance of XMT-1660 (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660 by measuring the rate at which the drug is eliminated from the body
3 years
Apparent terminal elimination half-life of XMT-1660 (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660
3 years
Volume of Distribution (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660
3 years
Trough concentration of XMT-1660 (Ctrough) (Dose Expansion)
Time Frame: 3 years
Assess the pharmacokinetics of XMT-1660 by measuring the lowest concentration of drug before dosing
3 years
Duration of response (DOR) (Dose Escalation and Dose Expansion)
Time Frame: Up to approximately 3 years
The time from when response criteria are first met until disease progression or death in participants who achieve a complete or partial response
Up to approximately 3 years
Assess antidrug antibodies (ADA) and neutralizing antibodies (nAB) (Dose Escalation and Dose Expansion)
Time Frame: 3 years
Assess the development of antidrug antibodies (ADA) and neutralizing antibodies (nAb) to XMT-1660
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersana Therapeutics

Investigators

  • Study Director: Robert Burger, MD, Mersana Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MER-XMT-1660-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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