Brief Title
A Study of XMT-1660 in Participants With Solid Tumors
Official Title
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with XMT-1660 during the first cycle of treatment (Dose Escalation)
Secondary Outcome
Objective Response Rate (ORR) (Dose Escalation)
Condition
Triple Negative Breast Cancer
Intervention
XMT-1660
Study Arms / Comparison Groups
XMT-1660
Description: Single arm XMT-1660 alone (monotherapy)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
166
Start Date
June 2022
Completion Date
January 2026
Primary Completion Date
January 2025
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dr. Shin, MD, 617-715-8214, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05377996
Organization ID
MER-XMT-1660-1
Responsible Party
Sponsor
Study Sponsor
Mersana Therapeutics
Study Sponsor
Dr. Shin, MD, Study Director, Mersana Therapeutics
Verification Date
June 2022