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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 : March 20, 2024
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 Adenoid Cystic Carcinoma 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 : 319 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 : December 2026
Estimated Study Completion Date : May 2027

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:

  • 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
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: Caroline Rogalski 1-617-715-8214 medicalinformation@mersana.com

Locations
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Sponsors and Collaborators
Mersana Therapeutics
Investigators
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Study Director: Robert Burger, 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: March 20, 2024
Last Verified: March 2024
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
Carcinoma, Adenoid Cystic
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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type