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A Study of XMT-1660 in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05377996
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Mersana Therapeutics

Study Description
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Brief Summary:
A Study of XMT-1660 in Solid Tumors

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Breast Cancer Endometrial Cancer Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Drug: XMT-1660 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Time of maximum observed plasma concentration of XMT-1660 (Tmax) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660

  4. Maximum observed plasma concentration of XMT-1660 (Cmax) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660

  5. Area under the concentration-time curve of XMT-1660 (AUC) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660

  6. 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

  7. Apparent terminal elimination half-life of XMT-1660 (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660

  8. Volume of Distribution (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660

  9. 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

  10. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has proven 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
  • Participant must have at least one measurable lesion(s) as defined by RECIST version 1.1.
  • Participant must be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if medically feasible, prior to C1D1. If the investigator feels a biopsy is not medically feasible, an exemption request must be submitted to the study Medical Monitor for approval.

Exclusion Criteria:

  • Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin or maytansinoid 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.
  • Participant has current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations. Further, participants are excluded with the following characteristics:

  • Participant has 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05377996


Contacts
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Contact: William Downing 1-617-715-8214 medicalinformation@mersana.com

Locations
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United States, California
UC Irvine Health-Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Ritesh Parajuli         
Principal Investigator: Ritesh Parajuli         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Hyo Han, MD         
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kevin Kalinsky, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Antonio Giordano, MD, PhD         
United States, Michigan
Henry Ford Health Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Amy Weise         
United States, New York
New York University Langone Health Recruiting
New York, New York, United States, 10016
Contact: Sylvia Adams, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nour Abuhadra, MD         
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Erika P Hamilton, MD         
United States, Virginia
NEXT Oncology Virginia Recruiting
Fairfax, Virginia, United States, 22031
Contact: Alex Spira, MD, PhD         
United States, Washington
Summit Cancer Centers Recruiting
Spokane, Washington, United States, 99208
Contact: Arvind Chaudhry, MD, PhD         
Sponsors and Collaborators
Mersana Therapeutics
Investigators
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Study Director: Divya Gupta, MD Mersana Therapeutics
More Information
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Responsible Party: Mersana Therapeutics
ClinicalTrials.gov Identifier: NCT05377996    
Other Study ID Numbers: MER-XMT-1660-1
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Fallopian Tube Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adnexal Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Uterine Neoplasms
Uterine Diseases
Fallopian Tube Diseases