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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 : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Mersana Therapeutics

Tracking Information
First Submitted Date  ICMJE May 2, 2022
First Posted Date  ICMJE May 17, 2022
Last Update Posted Date September 16, 2022
Actual Study Start Date  ICMJE August 15, 2022
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2022)
  • 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/or recommended Phase 2 dose (RP2D) of XMT-1660
  • 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
  • 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
  • Duration of response (DOR) (Dose Expansion) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2022)
  • 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
  • Duration of response (DOR) (Dose Escalation) [ 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
  • Time of maximum observed plasma concentration of XMT-1660 (Tmax) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660
  • Maximum observed plasma concentration of XMT-1660 (Cmax) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660
  • Area under the concentration-time curve of XMT-1660 (AUC) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660
  • 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
  • Apparent terminal elimination half-life of XMT-1660 (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660
  • Volume of Distribution (Dose Expansion) [ Time Frame: 3 years ]
    Assess the pharmacokinetics of XMT-1660
  • 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
  • Assess antidrug antibodies (ADA) and neutralizing antibodies (nAB) (Dose Expansion) [ Time Frame: 3 years ]
    Assess the development of antidrug antibodies (ADA) and neutralizing antibodies (nAb) to XMT-1660
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of XMT-1660 in Participants With Solid Tumors
Official Title  ICMJE A Phase 1b, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors
Brief Summary A Study of XMT-1660 in Solid Tumors
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Triple Negative Breast Cancer
  • Breast Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
Intervention  ICMJE Drug: XMT-1660
XMT-1660 will be administered through a vein in your arm or port catheter (intravenously)
Study Arms  ICMJE Experimental: XMT-1660
Single arm XMT-1660 alone (monotherapy)
Intervention: Drug: XMT-1660
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2022)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William Downing 1-617-715-8214 clinicaltrials@mersana.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05377996
Other Study ID Numbers  ICMJE MER-XMT-1660-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Study Director: Ellie Im, MD Mersana Therapeutics
PRS Account Mersana Therapeutics
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP