This is a first in human (FIH), Phase 1 dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).
This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific EGFR and MUC1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Escalating doses of NEOK002
Recommended NEOK002 dose(s) for Expansion
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona DDU
Orlando, Florida, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGPart A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
Incidence and severity of DLTs during the first cycle of treatment in Part A
Time frame: 21 days
Part A: Incidence and Severity of Adverse Events (AEs)
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients in Part A
Time frame: Through study completion, estimated as 32 months
Part B: Investigator Assessment of Objective Response Rate (ORR)
Percentage of patients who achieve a confirmed objective response (ORR)
Time frame: Through study completion, estimated as 32 months
Part B: Duration of Response (DOR)
The time from the first documentation of tumor response (complete or partial) until disease progression or death.
Time frame: Through study completion, estimated as 32 months
Part B: Incidence of AEs
Incidence of TEAEs and SAEs in participants in Part B
Time frame: Through study completion, estimated as 32 months
Maximum Concentration (Cmax) of NEOK002
Assessment of plasma pharmacokinetics (PK) parameters of NEOK002: Cmax
Time frame: 21 days
Terminal Elimination Half Life (T1/2) of NEOK002
Assessment of plasma PK parameters of NEOK002: T1/2
Time frame: 21 days
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Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
RECRUITINGNEXT Oncology
Austin, Texas, United States
RECRUITINGSarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
RECRUITINGNEXT Oncology
Dallas, Texas, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITING