This is a Phase 1a/1b, multicenter, open-label, first-in-human (FIH) study with MX006 treatment in patients with selected tumor types known to express B7-H3. The study will include 2 parts: * Dose-escalation (Part A) * Dose-expansion (Part B) A maximum of 120 patients may be enrolled in this study. The primary objective of the dose escalation (PART A) is to evaluate the safety and tolerability of MX006 and determine the maximum-tolerated dose (MTD) and the recommended doses for expansion (RDE) in patients with selected solid tumors; whereas the primary objective of the dose expansion (PART B) is to evaluate the safety and tolerability of MX006 at the dose level (s) recommended in Part A.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Anti-B7-H3 ADC
Florida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Oncology Virginia
Fairfax, Virginia, United States
RECRUITINGFrequency and severity of adverse events (AEs) and serious adverse events (SAEs) for patients treated with MX006
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to Common Terminology Criteria for Adverse Events (version 6)
Time frame: From ICF signature until 30 days (AEs) and 90 days (SAEs) after last dose of MX006
Number of participants who experience a clinically significant change from baseline safety laboratory values
Change from baseline
Time frame: Collected from screening until end of treatment and 30 days follow-up
Frequency of dose interruptions and dose reductions for patients treated with MX006.
Frequency of dose interruptions and dose reductions for patients treated with MX006.
Time frame: From first dose until last dose, up to 1 year
Incidence of dose limiting toxicities (DLTs) (dose-escalation only) for patients treated with MX006.
DLTs are dose-limiting toxicities as defined in the study protocol.
Time frame: DLTs are collected during the first treatment cycle (21 days)
Number of participants who experience a clinically significant change from baseline in Eastern Cooperative Group Oncology (ECOG) performance status
Measured on a scale of from grades 0-5.
Time frame: Collected from screening until end of treatment and 30 days follow-up
Number of participants who experience a clinically significant change from baseline in 12-lead electrocardiograph (ECG) measurements
Time frame: Collected from screening until end of treatment and 30 days follow-up
Number of participants who experience a clinically significant change from baseline in blood pressure (vital signs)
Measured in mm Hg
Time frame: Collected from screening until end of treatment and 30 days follow-up
Number of participants who experience a clinically significant change from baseline in heart rate (vital signs)
Measured in beats per minutes
Time frame: Collected from screening until end of treatment and 30 days follow-up
Number of participants who experience a clinically significant change from baseline in respiratory rate (vital signs)
Measured in breaths per minute
Time frame: Collected from screening until end of treatment and 30 days follow-up
Number of participants who experience a clinically significant change from baseline in body temperature (vital signs)
Measured in degrees Celsius
Time frame: Collected from screening until end of treatment and 30 days follow-up
Evaluate the preliminary anti-tumor activity of MX006
Overall response rate (ORR), duration of response (DOR), progression-free survival (PFS)
Time frame: From screening until end of treatment, up to 1 year (follow-up for patients who discontinue treatment for reasons other than disease progression or initiation of other cancer therapy: 6 months (Part A) or 12 months (Part B)
Overall survival (OS)
Overall survival (OS) defined as the time between the start of treatment and death from any cause for patients treated with MX006.
Time frame: Through study completion, up to 48 months
Area under concentration time curve (AUC)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Maximum concentration of MX006 (Cmax)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Minimum concentration of MX006 (Cmin)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Time to maximum concentration of MX006 (Tmax)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Concentration of MX006 prior to next dose (Ctrough)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Terminal half-life of MX006 (t1/2)
PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Clearance of MX006 (CL)
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PK parameter
Time frame: Day 1 to end of treatment, up to approximately 1 year
Anti-drug antibody (ADA) response to MX006
Frequency of confirmed positive anti-drug antibody (ADA) responses, and, if applicable, neutralizing activity to MX006 after treatment with MX006
Time frame: Day 1 to end of treatment, up to approximately 1 year