A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
The first-in-human (FIH) study of XMT-2056 is a Phase 1, open-label study of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2. The XMT-2056 monotherapy trial will consist of dose escalation (DES) and expansion (EXP) parts. DES will be the dose-finding portion of the study to assess the safety and tolerability of XMT-2056 and determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D). The RP2D will be determined based on the totality of the clinical data, including safety and preliminary anti-tumor effect, PK, and relevant biomarker data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
University of South California
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
Frequency of dose-limiting toxicities (DLTs) associated with XMT-2056 during the first cycle of treatment (Dose Escalation)
Determine the maximum tolerated dose (MTD) of XMT-2056
Time frame: 15 months
Incidence of adverse events (Dose Escalation and Dose Expansion)
Assess the safety and tolerability of XMT-2056 by determining the number of patients with adverse events from date of first dose to 30 days post last dose.
Time frame: 3 years
Objective Response Rate (ORR) (Dose Expansion)
The percentage of patients with a best overall response of confirmed complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 3 years
Objective Response Rate (ORR) (Dose Escalation)
The percentage of patients with a best overall response of confirmed complete or partial response as assessed by the investigator per Resist Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 3 years
Duration of response (DOR) (Dose Escalation and Dose Expansion)
The time from when response criteria are first met until disease progression or death in participants who achieve a confirmed complete or partial response.
Time frame: 3 years
Disease control rate (DCR) (Dose Escalation and Dose Expansion)
The percentage of patients who achieve a complete response, partial response or stable disease as the result of study treatment
Time frame: 3 years
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Stanford University Medical Center
Stanford, California, United States
RECRUITINGAdventHealth Celebration
Celebration, Florida, United States
RECRUITINGEmory Healthcare, Emory Clinic
Atlanta, Georgia, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGNew York University Medical Oncology Associates
New York, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITING...and 4 more locations
Time of maximum observed plasma concentration of XMT-2056 (Tmax) (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XMT-2056
Time frame: 3 years
Maximum observed plasma concentration of XMT-2056 (Cmax) (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XMT-2056
Time frame: 3 years
Area under the concentration-time curve of XMT-2056 (AUC) (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XMT-2056
Time frame: 3 years
Systemic clearance of XMT-2056 (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XmT-2056 by measuring the rate at which the drug is eliminated from the body
Time frame: 3 years
Apparent terminal elimination of half-life of XMT-2056 (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XMT-2056
Time frame: 3 years
Volume of Distribution (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XMT-2056
Time frame: 3 years
Trough concentration of XMT-2056 (Ctrough) (Dose Escalation and Dose Expansion)
Assess the pharmacokinetics of XMT-2056 by measuring the lowest concentration of drug before dosing
Time frame: 3 years
Serum samples for analysis of XMT-2056 antidrug and neutralizing antibodies (ADA/nAb) (Dose Escalation and Dose Expansion)
Assess the development of antidrug antibodies (ADA) and neutralizing antibodies (nAB) to XMT-2056
Time frame: 3 years