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 B7-H3 x ROR1 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 NEOK001
Recommended Dose of NEOK001 for Expansion
Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGNEXT Oncology
Austin, Texas, United States
Part 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 participants in Part A
Time frame: Through study completion, estimated as 32 months
Part B: Investigator Assessment of Objective Response Rate (ORR)
Percentage of participants 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)
Assessment of plasma pharmacokinetics (PK) of NEOK001 maximum observed concentration (Cmax) of NEOK001.
Time frame: 21 days
Terminal Elimination Half Life (T1/2)
Assessment of plasma PK of NEOK001 terminal elimination half-life (T1/2).
Time frame: 21days
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NEXT Oncology
Dallas, Texas, United States
RECRUITINGSCRI at Mary Crowley
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