A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
Summary
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).
Detailed description
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.
Arms & interventions
- DrugNEOK001
Escalating doses of NEOK001
- DrugNEOK001 RDE
Recommended Dose of NEOK001 for Expansion
Outcome measures
Primary
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
Secondary
Part B: Incidence of AEs
Time frame: Through study completion, estimated as 32 months
Maximum Concentration (Cmax)
Time frame: 21 days
Terminal Elimination Half Life (T1/2)
Time frame: 21days
Eligibility criteria
Study locations (8)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
SCRI Oncology Partners
Nashville, Tennessee, 37203
NEXT Oncology
Austin, Texas, 78758
NEXT Oncology
Dallas, Texas, 75039
MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
Houston, Texas, 77054
NEXT Oncology
San Antonio, Texas, 78299
NEXT Oncology
Fairfax, Virginia, 22031